Covid 19 Research using Clinical Trials (Home Page)
Report for D060825: Cognitive Dysfunction NIH
(Synonyms: Cognitiv, Cognitive, Cognitive, Cognitive D, Cognitive Dysf, Cognitive Dysfu, Cognitive Dysfun, Cognitive Dysfunc, Cognitive Dysfunctio, Cognitive Dysfunction)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (30)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug568 | COVID-19 swap test PCR Wiki | 0.32 |
| drug2856 | Telephone interview Wiki | 0.32 |
| drug1412 | Information leaflet Wiki | 0.32 |
| drug979 | Electric pad for human external pain therapy Wiki | 0.32 |
| drug2351 | RT-PCR Wiki | 0.32 |
| drug1403 | Independent Living Program for Affordable Housing. Wiki | 0.32 |
| drug1797 | Muse headband with Myndlift app Wiki | 0.32 |
| drug1486 | Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki | 0.32 |
| drug1185 | Goal Management Training (GMT) Wiki | 0.32 |
| drug771 | Cooking Training Wiki | 0.32 |
| drug2836 | Technology based social interactions Wiki | 0.32 |
| drug952 | ELISA Wiki | 0.32 |
| drug976 | Eicosapentaenoic acid gastro-resistant capsules Wiki | 0.32 |
| drug2824 | Table Setting Training Wiki | 0.32 |
| drug953 | ELISA and Rapid test to detect antibodies against COVID-19 Wiki | 0.32 |
| drug1895 | No research related technology based social interactions Wiki | 0.32 |
| drug924 | Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki | 0.32 |
| drug368 | Bacillus Calmette-Guerin (BCG) Wiki | 0.32 |
| drug698 | Cognitive Stimulation Wiki | 0.32 |
| drug3098 | WALC-R Wiki | 0.32 |
| drug1789 | Multi-tasking Training Wiki | 0.32 |
| drug376 | Baricitinib Wiki | 0.24 |
| drug2093 | Peripheral blood draw Wiki | 0.22 |
| drug968 | Echocardiography Wiki | 0.22 |
| drug2955 | Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit Wiki | 0.22 |
| drug939 | Duvelisib Wiki | 0.22 |
| drug922 | Doxycycline Wiki | 0.16 |
| drug2730 | Standard treatment Wiki | 0.13 |
| drug2413 | Remdesivir Wiki | 0.07 |
| drug2122 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003072 | Cognition Disorders NIH | 0.45 |
| D019965 | Neurocognitive Disorders NIH | 0.32 |
| D000544 | Alzheimer Disease NIH | 0.32 |
| D008569 | Memory Disorders NIH | 0.32 |
| D003704 | Dementia NIH | 0.32 |
| D004827 | Epilepsy NIH | 0.32 |
| D012640 | Seizures NIH | 0.22 |
| D009422 | Nervous System Diseases NIH | 0.18 |
| D020521 | Stroke NIH | 0.09 |
| D040921 | Stress Disorders, Traumatic NIH | 0.06 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.06 |
Correlated HPO Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001268 | Mental deterioration HPO | 1.00 |
| HP:0002354 | Memory impairment HPO | 0.32 |
| HP:0002511 | Alzheimer disease HPO | 0.32 |
| HP:0000726 | Dementia HPO | 0.32 |
| HP:0001250 | Seizure HPO | 0.18 |
| HP:0001297 | Stroke HPO | 0.09 |
There are 10 clinical trials
Clinical Trials
1 Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
The aging US population threatens to overwhelm our healthcare infrastructure, especially since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades. Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies those with memory deficits but who remain relatively independent in everyday life. MCI provides a window for interventions that target memory functioning. The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from different types of memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.
NCT02155946 Mild Cognitive Impairment Alzheimer's Disease Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit MeSH:Alzheimer Disease Cognitive Dysfunction
HPO:Alzheimer disease Cognitive impairment Mental deterioration
Primary Outcomes
Description: Changes in task related and resting state BOLD activation.
Measure: Functional MRI Time: 3 months
Description: Performance measured using percent correct
Measure: Face-name memory test performance Time: change from baseline
Description: Performance measured using deviation from target position
Measure: Object Location Association memory test performance Time: change from baseline
Description: Changes in task related and resting state BOLD activation.
Measure: fMRI Time: change from baseline to 3 months
Description: Performance measured using percent correct
Measure: Face-name memory test performance Time: change from baseline to 3 months
Description: Performance measured using deviation from target position
Measure: Object Location Association memory test performance Time: change from baseline to 3 months
Secondary Outcomes
Description: Performance on prose (medical instructions) and spatial (navigation) memory tasks
Measure: Objective memory test performance Time: 3 months
Description: Changes on the Multifactorial Memory Questionnaire
Measure: Subjective memory test performance on the MMQ Time: 3 months
Description: Performance on prose (medical instructions) and spatial (navigation) memory tasks
Measure: Objective memory test performance Time: change from baseline to 3 months
Description: Changes on the Multifactorial Memory Questionnaire
Measure: Subjective memory test performance on the MMQ Time: change from baseline to 3 months
Other Outcomes
Description: Planned analyses to examine patient specific characteristics that affect treatment efficacy and would be vital for clinical translation at the individual patient level. These include: Neuropsychological test scores, brain volumes/cortical thickness, and other possible MRI factors.
Measure: Planned (tertiary) analyses of patient-specific characteristics that affect treatment outcome Time: post treatment (within ~ 96 hours) & 3 months
2 Cognitive Training in a Multi-task Daily Life Task: a Feasibility Study in Healthy Older Adults
Primary Outcomes
Description: Changes in task related and resting state BOLD activation.
Measure: Functional MRI Time: 3 monthsDescription: Performance measured using percent correct
Measure: Face-name memory test performance Time: change from baselineDescription: Performance measured using deviation from target position
Measure: Object Location Association memory test performance Time: change from baselineDescription: Changes in task related and resting state BOLD activation.
Measure: fMRI Time: change from baseline to 3 monthsDescription: Performance measured using percent correct
Measure: Face-name memory test performance Time: change from baseline to 3 monthsDescription: Performance measured using deviation from target position
Measure: Object Location Association memory test performance Time: change from baseline to 3 monthsSecondary Outcomes
Description: Performance on prose (medical instructions) and spatial (navigation) memory tasks
Measure: Objective memory test performance Time: 3 monthsDescription: Changes on the Multifactorial Memory Questionnaire
Measure: Subjective memory test performance on the MMQ Time: 3 monthsDescription: Performance on prose (medical instructions) and spatial (navigation) memory tasks
Measure: Objective memory test performance Time: change from baseline to 3 monthsDescription: Changes on the Multifactorial Memory Questionnaire
Measure: Subjective memory test performance on the MMQ Time: change from baseline to 3 monthsOther Outcomes
Description: Planned analyses to examine patient specific characteristics that affect treatment efficacy and would be vital for clinical translation at the individual patient level. These include: Neuropsychological test scores, brain volumes/cortical thickness, and other possible MRI factors.
Measure: Planned (tertiary) analyses of patient-specific characteristics that affect treatment outcome Time: post treatment (within ~ 96 hours) & 3 monthsThis study evaluated the feasibility of a web-based computerized cognitive training protocol to healthy older adults. The training protocol will occur in two phases. In the first phase, participants will be randomly allocated in one type of training, and in the second phase all participants will receive the same training.
NCT04195230 Age-related Cognitive Decline Behavioral: Table Setting Training Behavioral: Cooking Training Behavioral: Multi-tasking Training MeSH:Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
Primary Outcomes
Description: Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lowers scores (closest to zero) represent a better outcome.
Measure: Change in Cooking Time Discrepancy Scores Time: During intervention: baseline, two weeks, and one month
Description: Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect is the difference between the first and last food item stopped cooking. Lowers scores (closest to zero) represent a better outcome.
Measure: Change in Range of Stop Times Score Time: During intervention: baseline, two weeks, and one month
Description: Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests, when finished, one point is given. Higher scores represent a better outcome.
Measure: Change in the Number of Tables Set Score Time: During intervention: baseline, two weeks, and one month
Secondary Outcomes
Description: The participants are asked to identify targets and ignore distracting visual information under different conditions. Scores are automatically generated by the software based on the accuracy and reaction time of performance. Higher scores reflect better cognitive ability.
Measure: Transfer to Speed Processing Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: Participants are presented with a computer screen of 9 boxes. The boxes light up in a pre-fixed sequence and participants are asked to click on the boxes in the same order they were lit. The sequence length starts at level = 2 boxes and can increase to up to level 9. One point is giving for each correct response. Higher values represent better performance (min 0; max of 16 points).
Measure: Transfer to Visuospatial Working Memory Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: Participants are asked to read words and identify letter under different conditions. Scores are based on performance time (seconds) and number of errors.
Measure: Transfer to Inhibitory Control Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: Participants listen to series of letters and digits, which they need to organize under specific conditions. One point is giving for each correct response (mix 0; max 30 points).
Measure: Transfer to Verbal Working Memory Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: It consists in a test that target three attentional networks involving identifying targets. Lower score represent faster performance.
Measure: Transfer to Complex Attention Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: It consist in letters and numbers operations. Accuracy on the alphabetic portion of the Alpha-span task.
Measure: Transfer to Complex Working Memory Task: the Alpha-span task (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: Average z-score computed with outcomes 4 to 9.
Measure: Transfer to Executive Control Composite Score (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
Description: Questionnaire listing cognitive failures in everyday life (self-report measure). Higher scores reflect more cognitive failures or difficulties.
Measure: Transfer to self-report cognitive failure questionnaire (Change) Time: Baseline, two weeks (during the intervention), within one week after the intervention
3 Improving Aging in Place for Older Adults in Subsidized Housing
Primary Outcomes
Description: Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lowers scores (closest to zero) represent a better outcome.
Measure: Change in Cooking Time Discrepancy Scores Time: During intervention: baseline, two weeks, and one monthDescription: Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect is the difference between the first and last food item stopped cooking. Lowers scores (closest to zero) represent a better outcome.
Measure: Change in Range of Stop Times Score Time: During intervention: baseline, two weeks, and one monthDescription: Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests, when finished, one point is given. Higher scores represent a better outcome.
Measure: Change in the Number of Tables Set Score Time: During intervention: baseline, two weeks, and one monthSecondary Outcomes
Description: The participants are asked to identify targets and ignore distracting visual information under different conditions. Scores are automatically generated by the software based on the accuracy and reaction time of performance. Higher scores reflect better cognitive ability.
Measure: Transfer to Speed Processing Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: Participants are presented with a computer screen of 9 boxes. The boxes light up in a pre-fixed sequence and participants are asked to click on the boxes in the same order they were lit. The sequence length starts at level = 2 boxes and can increase to up to level 9. One point is giving for each correct response. Higher values represent better performance (min 0; max of 16 points).
Measure: Transfer to Visuospatial Working Memory Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: Participants are asked to read words and identify letter under different conditions. Scores are based on performance time (seconds) and number of errors.
Measure: Transfer to Inhibitory Control Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: Participants listen to series of letters and digits, which they need to organize under specific conditions. One point is giving for each correct response (mix 0; max 30 points).
Measure: Transfer to Verbal Working Memory Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: It consists in a test that target three attentional networks involving identifying targets. Lower score represent faster performance.
Measure: Transfer to Complex Attention Task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: It consist in letters and numbers operations. Accuracy on the alphabetic portion of the Alpha-span task.
Measure: Transfer to Complex Working Memory Task: the Alpha-span task (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: Average z-score computed with outcomes 4 to 9.
Measure: Transfer to Executive Control Composite Score (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionDescription: Questionnaire listing cognitive failures in everyday life (self-report measure). Higher scores reflect more cognitive failures or difficulties.
Measure: Transfer to self-report cognitive failure questionnaire (Change) Time: Baseline, two weeks (during the intervention), within one week after the interventionThis pilot study will evaluate the feasibility and preliminary effectiveness of an adapted version of the Function Focused Care intervention, delivered by telephone, for improving aging in place for older adults living in subsidized housing. The study will include participants with and without mild cognitive impairment or mild dementia and will examine whether the study outcomes differ by cognitive status. Findings from this study will provide new information about how to optimize function and physical activity among older adults with and without cognitive impairment living in subsidized housing.
NCT04212442 Physical Disability Cognitive Impairment Physical Activity Behavioral: Independent Living Program for Affordable Housing. MeSH:Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
Primary Outcomes
Description: Self-reported ability to perform 8 ADLs and 7 IADLs (Range, 0-30; higher scores indicate more functional impairment)
Measure: Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Description: Objective measure of lower extremity functioning in older adults (Range, 0-12; higher scores indicate worse lower extremity functioning)
The measure will be collected only if in-person contact is possible during the COVID-19 outbreak.
Measure: Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Description: Measured using Fitbit
Measure: Change in average step counts from baseline to 2 months for immediate intervention sites; change from 2 to 4 months for waitlist control sites Time: Measured continuously from 0-4 months
Description: Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
Measure: Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: 0-4 months
Description: Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
Measure: Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Secondary Outcomes
Description: Self-reported measure (Range, 13-52; higher scores indicate better quality of life)
Measure: Change in Quality of Life in Alzheimer's Disease (QOL-AD) scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported measure of depressive symptoms (Range, 0-27; higher scores indicate worse depressive symptoms)
Measure: Change in Patient Health Questionnaire (PHQ-9) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Description: 14-item self-reported scale (Range, 14-98; higher scores indicate higher levels of resilience)
Measure: Change in Resilience Scale (RS-14) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported hospitalization
Measure: Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported number of hospitalizations
Measure: Number of hospitalizations during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported emergency department visit
Measure: Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported number of emergency department visits
Measure: Number of emergency department visits during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list control
Description: Self-reported or emergency contact-reported move to a higher level of care, defined as a move to assisted living, board and care, or nursing home
Measure: Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list control
Description: Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)
Measure: Feasibility of study recruitment, measured as percentage of eligible participants recruited Time: 0-4 months
Description: Assessed as percentage of participants who remain enrolled in the study
Measure: Feasibility of study retention, measured as percentage of participants retained over study follow-up Time: 0-4 months
Description: Fidelity checklist including each component, with fidelity measured as the percentage of total study protocol tasks completed (Range, 0-100%; higher percentage indicates higher fidelity)
Measure: Percentage fidelity to treatment protocol, measured using fidelity checklist Time: 0-4 months
Description: Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))
Measure: Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4) Time: 0-4 months
Description: Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)
Measure: Acceptability assessed using a survey question Time: 0-4 months
Description: Self-reported acceptability of the intervention assessed using open-ended questions (e.g., "How did the program fit into your life?"; no pre-specified range as responses are qualitative; more positive responses indicate higher acceptability)
Measure: Acceptability assessed using qualitative interviews Time: 0-4 months
4 COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
Primary Outcomes
Description: Self-reported ability to perform 8 ADLs and 7 IADLs (Range, 0-30; higher scores indicate more functional impairment)
Measure: Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlDescription: Objective measure of lower extremity functioning in older adults (Range, 0-12; higher scores indicate worse lower extremity functioning) The measure will be collected only if in-person contact is possible during the COVID-19 outbreak.
Measure: Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlDescription: Measured using Fitbit
Measure: Change in average step counts from baseline to 2 months for immediate intervention sites; change from 2 to 4 months for waitlist control sites Time: Measured continuously from 0-4 monthsDescription: Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)
Measure: Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: 0-4 monthsDescription: Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)
Measure: Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlSecondary Outcomes
Description: Self-reported measure (Range, 13-52; higher scores indicate better quality of life)
Measure: Change in Quality of Life in Alzheimer's Disease (QOL-AD) scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported measure of depressive symptoms (Range, 0-27; higher scores indicate worse depressive symptoms)
Measure: Change in Patient Health Questionnaire (PHQ-9) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlDescription: 14-item self-reported scale (Range, 14-98; higher scores indicate higher levels of resilience)
Measure: Change in Resilience Scale (RS-14) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported hospitalization
Measure: Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported number of hospitalizations
Measure: Number of hospitalizations during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported emergency department visit
Measure: Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported number of emergency department visits
Measure: Number of emergency department visits during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list controlDescription: Self-reported or emergency contact-reported move to a higher level of care, defined as a move to assisted living, board and care, or nursing home
Measure: Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites) Time: Baseline, 2 months, 4 months for wait-list controlDescription: Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)
Measure: Feasibility of study recruitment, measured as percentage of eligible participants recruited Time: 0-4 monthsDescription: Assessed as percentage of participants who remain enrolled in the study
Measure: Feasibility of study retention, measured as percentage of participants retained over study follow-up Time: 0-4 monthsDescription: Fidelity checklist including each component, with fidelity measured as the percentage of total study protocol tasks completed (Range, 0-100%; higher percentage indicates higher fidelity)
Measure: Percentage fidelity to treatment protocol, measured using fidelity checklist Time: 0-4 monthsDescription: Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))
Measure: Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4) Time: 0-4 monthsDescription: Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)
Measure: Acceptability assessed using a survey question Time: 0-4 monthsDescription: Self-reported acceptability of the intervention assessed using open-ended questions (e.g., "How did the program fit into your life?"; no pre-specified range as responses are qualitative; more positive responses indicate higher acceptability)
Measure: Acceptability assessed using qualitative interviews Time: 0-4 monthsThe purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms
NCT04377425 Neurological Diseases or Conditions Stroke, Acute Seizure Disorder Diagnostic Test: COVID-19 swap test PCR MeSH:Stroke Seizures Epilepsy Cognition Disorders Cognitive Dysfunction Nervous System Diseases
HPO:Bilateral tonic-clonic seizure Cognitive impairment Focal sensory seizure Focal-onset seizure Generalized-onset seizure Mental deterioration Seizure Stroke
Primary Outcomes
Description: To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
Measure: Prevalence of COVID-19 infection in consecutive patients with neurological symptoms Time: 6 months
Secondary Outcomes
Description: Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
Measure: Three months cognitive function of COVID-19 positive patients Time: 3 months
Description: Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
Measure: Clinical presentation of neurological symptoms in COVID-19 positive patients Time: 6 months
Description: Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
Measure: Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients Time: 6 months
Description: Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
Measure: Anosmia in COVID-19 positive patients Time: 6 months
Description: Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
Measure: Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection Time: 24 months
Description: Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
Measure: Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients Time: 24 months
5 Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia
Primary Outcomes
Description: To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
Measure: Prevalence of COVID-19 infection in consecutive patients with neurological symptoms Time: 6 monthsSecondary Outcomes
Description: Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
Measure: Three months cognitive function of COVID-19 positive patients Time: 3 monthsDescription: Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
Measure: Clinical presentation of neurological symptoms in COVID-19 positive patients Time: 6 monthsDescription: Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
Measure: Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients Time: 6 monthsDescription: Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
Measure: Anosmia in COVID-19 positive patients Time: 6 monthsDescription: Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
Measure: Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection Time: 24 monthsDescription: Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
Measure: Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients Time: 24 monthsCoronavirus disease 2019 has forced worldwide the implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine and home confinement. This restriction of daily life activities and separation from loved ones may lead to social isolation and loneliness with health-related consequences in community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, an inadequate access to healthcare and social support services may aggravate chronic conditions. Technology home-based interventions emerge for combating social isolation and loneliness preventing the risk of viral exposure. The aim of this multicentre cohort study is to explore, analyze and determine the impact of social isolation on: 1) cognition, quality of life, mood, technophilia and perceived stress of community-dwelling older adults with mild cognitive impairment or mild dementia, and on caregiver burden; 2) health and social care services access and utilization, and 3) cognitive, social and entertainment use of ICTs. This study will be conducted in two Spanish regions AndalucÃa (Málaga) and Cataluña (Tarrasa). In total 414 dyads, consisting of a person with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregiver will be contacted by telephone. Potential respondents will be participants of the SMART 4 MD (N=2921), TV-AssistDem (N=100) and INFINITy (N=23) clinical trials. The change in means in the variables will be analyzed comparing baseline results in the previous studies with those during and after confinement using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used.
NCT04385797 Mild Cognitive Impairment Dementia Other: Telephone interview MeSH:Dementia Cognitive Dysfunction
HPO:Cognitive impairment Dementia Mental deterioration
Primary Outcomes
Description: The Mini-Mental State Examination (MMSE) (23) will be used to assess the cognitive function of the PMCI/MD. The most common cutoff scores for cognitive impairment and dementia are ranging 23 to 27 over 30. As telephone call interviewing will be the safest means to communicate with the PMCI/MD during and after the COVID-19 pandemic the 22 items telephone version of the MMSE will be used (24). All points of the MMSE can be covered in the telephone version except the last section assessing language and motor skills. In the phone version, we will ask the subject to repeat a phrase and name one item (For example: "Tell me, what is the name of the object you are using to talk to me?"). However, a second item will be not be named, nor will be the person be asked to follow a three-stage command, read and obey a sentence, write a sentence, or copy an intersecting pentagon as in the original version.
Measure: Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 months
Secondary Outcomes
Description: The Quality of Life-Alzheimer's Disease Scale (QoL-AD) (19-22) is an instrument specifically designed to measure QoL in PMCI/MD from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory, and an overall assessment of life quality. Response are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life.
When cognitive function may be compromised, informal caregivers will complete the QoL-AD, on behalf of the PMCI/MD.
Measure: Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: The European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS).
The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, moderate problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state.
The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 100 = 'The best health you can imagine' and 0 = 'The worst health you can imagine'.
EuroQoL-5D-3L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible.
Measure: Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: The Short Form of the Geriatric Depression Scale (GDS) (25) will be used to assess mood. Of the 15 items, 10 indicate depression when answered positively, while the rest (1, 5, 7, 11, 13) when answered negatively. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 moderate depression, and 12-15 severe depression.
Measure: Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: The Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) measures older people's attitudes and enthusiasm for health technology (26). This instrument refers to technophilia as a person's enthusiasm for and positive feelings toward their technology use and absence of the fears and doubts some older people could have about their ability to manage using new technology. The six items of the instrument measure two factors of technophilia: 3 items concerning techEnthusiasm and 3 items techAnxiety. Response are constructed with a five-point Likert scale questionnaire, ranging from 1 (fully disagree) to 5 (fully agree).
Measure: Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful. The scale has 10 questions regarding feelings and thoughts during the last month and are rated according to frecuency 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items
Measure: Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement. Time: Through study completion, an average of 6 months
Description: The Zarit Burden Interview (ZBI-12) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden >20= high burden).
Measure: Change on caregiver burden prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: The Client Service Receipt Inventory (CSRI) (32,33) scale will be used to evaluate the service utilization. This scale is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required.
Measure: Change on healthcare and social support services access prior to, during and after confinement. Time: Through study completion, an average of 6 months
Description: Use of ICTs (SmartPhone, Tablet, Computer, Smart-TV, or other) to contact healthcare and social support services, to stimulate cognition, to facilitate social connectedness (telephone call, video call, texting...), to access COVID-19 information and to enable entertainment.
Measure: Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement. Time: Through study completion, an average of 6 months
6 Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable
Primary Outcomes
Description: The Mini-Mental State Examination (MMSE) (23) will be used to assess the cognitive function of the PMCI/MD. The most common cutoff scores for cognitive impairment and dementia are ranging 23 to 27 over 30. As telephone call interviewing will be the safest means to communicate with the PMCI/MD during and after the COVID-19 pandemic the 22 items telephone version of the MMSE will be used (24). All points of the MMSE can be covered in the telephone version except the last section assessing language and motor skills. In the phone version, we will ask the subject to repeat a phrase and name one item (For example: "Tell me, what is the name of the object you are using to talk to me?"). However, a second item will be not be named, nor will be the person be asked to follow a three-stage command, read and obey a sentence, write a sentence, or copy an intersecting pentagon as in the original version.
Measure: Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsSecondary Outcomes
Description: The Quality of Life-Alzheimer's Disease Scale (QoL-AD) (19-22) is an instrument specifically designed to measure QoL in PMCI/MD from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory, and an overall assessment of life quality. Response are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life. When cognitive function may be compromised, informal caregivers will complete the QoL-AD, on behalf of the PMCI/MD.
Measure: Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, moderate problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state. The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 100 = 'The best health you can imagine' and 0 = 'The worst health you can imagine'. EuroQoL-5D-3L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible.
Measure: Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Short Form of the Geriatric Depression Scale (GDS) (25) will be used to assess mood. Of the 15 items, 10 indicate depression when answered positively, while the rest (1, 5, 7, 11, 13) when answered negatively. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 moderate depression, and 12-15 severe depression.
Measure: Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) measures older people's attitudes and enthusiasm for health technology (26). This instrument refers to technophilia as a person's enthusiasm for and positive feelings toward their technology use and absence of the fears and doubts some older people could have about their ability to manage using new technology. The six items of the instrument measure two factors of technophilia: 3 items concerning techEnthusiasm and 3 items techAnxiety. Response are constructed with a five-point Likert scale questionnaire, ranging from 1 (fully disagree) to 5 (fully agree).
Measure: Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful. The scale has 10 questions regarding feelings and thoughts during the last month and are rated according to frecuency 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items
Measure: Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Zarit Burden Interview (ZBI-12) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden >20= high burden).
Measure: Change on caregiver burden prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Client Service Receipt Inventory (CSRI) (32,33) scale will be used to evaluate the service utilization. This scale is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required.
Measure: Change on healthcare and social support services access prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: Use of ICTs (SmartPhone, Tablet, Computer, Smart-TV, or other) to contact healthcare and social support services, to stimulate cognition, to facilitate social connectedness (telephone call, video call, texting...), to access COVID-19 information and to enable entertainment.
Measure: Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement. Time: Through study completion, an average of 6 monthsThe aim of the intervention proposed in the present study is to assess the effect of a cognitive stimulation (CS) intervention program in an individual and long-term format, for non-institutionalized elderly people with neurocognitive disorders and in a situation of social vulnerability. Specifically, to test the effectiveness of CS on the global cognitive state, on mood state, on quality of life and on functional state. The program will be composed by 50 sessions, including three of assessment sessions (pre, intra and post-intervention). Each session will have a duration of 45 minutes with a weekly frequency. Control group participants will maintain their treatment as usual.
NCT04417751 Neurocognitive Disorders Dementia Cognitive Impairment Cognitive Decline Cognitive Dysfunction Social Behavior Behavioral: Cognitive Stimulation MeSH:Dementia Cognitive Dysfunction Neurocognitive Disorders
HPO:Cognitive impairment Dementia Mental deterioration
Primary Outcomes
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability.
Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Cognitive state evaluated through Mini-Mental State Examination Time: Pre-intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability.
Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 6 months after the beginning of the intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability.
Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 12 months after the beginning of the intervention
Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Cognitive performance evaluated through Montreal Cognitive Assessment Time: Pre-intervention
Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 6 months after the beginning of the intervention
Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 12 months after the beginning of the intervention
Secondary Outcomes
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Depressive symptoms evaluated through Geriatric Depression Scale -15 Time: Pre intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 6 months after the beginning of the intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 12 months after the beginning of the intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: Pre-intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 6 months after the beginning of the intervention
Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 12 months after the beginning of the intervention
Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: Pre-intervention
Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 6 months after the beginning of the intervention
Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 12 months after the beginning of the intervention
Other Outcomes
Description: Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.
Measure: Sociodemographic data collected through a sociodemographic questionnaire Time: Pre-intervention
Description: Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.
Measure: Adherence to the intervention and dropouts evaluated through a session form Time: [Pre, intra (6 months) and post intervention (12 months)]
7 A Randomized Control Trial Examining the Treatment Efficacy of a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder and Co-Morbid Conditions
Primary Outcomes
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Cognitive state evaluated through Mini-Mental State Examination Time: Pre-interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 12 months after the beginning of the interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Cognitive performance evaluated through Montreal Cognitive Assessment Time: Pre-interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 6 months after the beginning of the interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 12 months after the beginning of the interventionSecondary Outcomes
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Depressive symptoms evaluated through Geriatric Depression Scale -15 Time: Pre interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 12 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: Pre-interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 12 months after the beginning of the interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: Pre-interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 6 months after the beginning of the interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 12 months after the beginning of the interventionOther Outcomes
Description: Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.
Measure: Sociodemographic data collected through a sociodemographic questionnaire Time: Pre-interventionDescription: Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.
Measure: Adherence to the intervention and dropouts evaluated through a session form Time: [Pre, intra (6 months) and post intervention (12 months)]This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder) in certain populations. Participants will be randomized to either GMT group treatment (with or without use of a mindfulness meditation aid), or a wait-list condition.
NCT04457271 PTSD Post-traumatic Stress Disorder Cognitive Impairment Cognitive Dysfunction Cognitive Deficit Behavioral: Goal Management Training (GMT) Device: Muse headband with Myndlift app MeSH:Cognitive Dysfunction Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Cognition Disorders
HPO:Cognitive impairment Mental deterioration
Primary Outcomes
Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
Measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment Time: 9 weeks
Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
Measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment Time: 12 weeks
Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from baseline to post-treatment assessment. Time: 9 weeks
Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from post-treatment to 3-month follow-up assessment. Time: 12 weeks
Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment Time: 9 weeks
Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment Time: 12 weeks
Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
Measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment Time: 9 weeks
Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
Measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment Time: 12 weeks
8 Sedentary Behaviour and Cognitive Function in Community Dwelling Older People: A Feasibility Study
Primary Outcomes
Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
Measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment Time: 9 weeksDescription: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
Measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment Time: 12 weeksDescription: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from baseline to post-treatment assessment. Time: 9 weeksDescription: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from post-treatment to 3-month follow-up assessment. Time: 12 weeksDescription: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment Time: 9 weeksDescription: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment Time: 12 weeksDescription: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
Measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment Time: 9 weeksDescription: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
Measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment Time: 12 weeksIntroduction Sedentary behaviour refers to activities of low energy expenditure in lying and sitting positions. Examples include driving, watching television, playing cards, puzzles and working on a computer. Studies suggest that between 60% of older people world-wide reported sitting for more than four hours per day. Sedentary behaviour increases as older people become older, have problems with cognition and when they are very ill. Excessive participating in sedentary behaviours is associated with an increased risk of heart problem, cancer death and diabetes. However, we do not know for certain whether or not participating in sedentary behaviour could cause poorer cognition. What does the study hope to achieve? This feasibility study will test whether the main study, which is planned for later, is workable with regards to the following: - Will reducing sedentary behaviour using our online health coaching intervention (WALC-R) be acceptable to research participants and caregivers? - How many participants can be successfully recruited to the future trial? - What is the rate of adverse event associated with proposed study intervention? Method: This is a 13-week randomised feasibility study. We will randomly assign study participants to either the health coaching intervention (WALC-R) or receiving health guidelines on recommended physical activity. We aim to recruit 40 participants aged 50 and over who have been diagnosed with Mild Cognitive Impairment. The future main study will be larger and test whether: • 'WALC-R', an online intervention designed to reduce participation in sedentary behaviour can improve cognitive function in older people with Mild Cognitive Impairment compared with providing an information sheet about physical activity.
NCT04464538 Mild Cognitive Impairment Behavioral: WALC-R Other: Information leaflet MeSH:Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
Primary Outcomes
Description: Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.
Measure: Acceptability of intervention assessed by semi-structured interviews Time: Week 13
Description: Proportion of target recruit sample achieved throughout study duration.
Measure: Recruitment rate Time: Week 13
Description: Proportion of participants recruited into the study who completed the intervention.
Measure: Completeness of intervention Time: Week 13
Description: Proportion of people recruited into the study who sustained adverse events.
Measure: Adverse event rate Time: Week 13
Secondary Outcomes
Description: Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity).
Measure: Device measured sedentary behaviour Time: Week 1 and 13
Description: Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', <=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours.
Measure: Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire Time: Week 1 and 13
Description: The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa.
Measure: Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT) Time: Week 1 and 13
Description: The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa.
Measure: Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D) Time: Week 1 and 13
9 Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
Primary Outcomes
Description: Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.
Measure: Acceptability of intervention assessed by semi-structured interviews Time: Week 13Description: Proportion of target recruit sample achieved throughout study duration.
Measure: Recruitment rate Time: Week 13Description: Proportion of participants recruited into the study who completed the intervention.
Measure: Completeness of intervention Time: Week 13Description: Proportion of people recruited into the study who sustained adverse events.
Measure: Adverse event rate Time: Week 13Secondary Outcomes
Description: Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity).
Measure: Device measured sedentary behaviour Time: Week 1 and 13Description: Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', <=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours.
Measure: Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire Time: Week 1 and 13Description: The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa.
Measure: Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT) Time: Week 1 and 13Description: The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa.
Measure: Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D) Time: Week 1 and 13The current study will examine the impact of frequent social interaction through communication technologies during COVID-19 pandemic in the cognitive status of socially-isolated older adults with and without cognitive impairment. Patients will take place in an experimental crossover study, participants will complete one month of an intervention and one month of as passive control. The goal of this study is to determine: A.) if frequent social interaction through ICT during COVID-19 pandemic will have a significant positive impact in cognitive performance on testing, and B.) how social isolation and cognitive status influence misconceptions around the current pandemic.
NCT04480112 Memory Disorders Alzheimer Disease Mild Cognitive Impairment Behavioral: Technology based social interactions Other: No research related technology based social interactions MeSH:Alzheimer Disease Memory Disorders Cognitive Dysfunction
HPO:Alzheimer disease Cognitive impairment Memory impairment Mental deterioration
Primary Outcomes
Description: The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.
Measure: Change in memory performance Time: Baseline,1 month
Description: Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.
Measure: Change in cognition Time: Baseline, 1 month
Description: Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.
Measure: Change in phonemic fluency Time: Baseline, 1 month
Secondary Outcomes
Description: The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.
Measure: Social isolation Time: 1 month
Description: Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O ("I often feel this way"= 3),S ("I sometimes feel this way"=2), R ("I rarely feel this way"=1), N ("I never feel this way"=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.
Measure: Loneliness Time: 1 month
Description: The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measure: Depressive symptoms Time: 1 month
Description: An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.
Measure: Misinformation about Covid-19 Time: 1 month
10 Effects of BCG Immunization on Cerebrospinal Fluid and Blood-Based Biomarkers in Older Adults: A Pilot
Primary Outcomes
Description: The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.
Measure: Change in memory performance Time: Baseline,1 monthDescription: Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.
Measure: Change in cognition Time: Baseline, 1 monthDescription: Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.
Measure: Change in phonemic fluency Time: Baseline, 1 monthSecondary Outcomes
Description: The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.
Measure: Social isolation Time: 1 monthDescription: Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O ("I often feel this way"= 3),S ("I sometimes feel this way"=2), R ("I rarely feel this way"=1), N ("I never feel this way"=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.
Measure: Loneliness Time: 1 monthDescription: The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measure: Depressive symptoms Time: 1 monthDescription: An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.
Measure: Misinformation about Covid-19 Time: 1 monthA pilot study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older adults.
NCT04507126 Mild Cognitive Impairment Healthy Biological: Bacillus Calmette-Guerin (BCG) MeSH:Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
Primary Outcomes
Description: Change in concentration of circulating cytokines in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response- cytokines Time: Day 84
Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-Treg Time: Day 84
Description: Change in soluble TNF receptor (sTNF-R) concentration in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-TNFR Time: Day 84
Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in CSF from baseline.
Measure: CSF biomarkers of AD pathology-ATN Time: Day 84
Description: Change in BCG on molecular markers of immune response (YKL40, and sTREM2) concentration from from Baseline.
Measure: CSF biomarkers of immune response. Time: Day 84
Description: Change in concentration of circulating cytokines in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 28
Description: Change in concentration of Treg number and proportion (relative to total CD4+ and CD8+ T cells) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-Treg Time: Day 28
Description: Change in concentration of Soluble TNF receptor (sTNF-R) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-TNFR Time: Day 28
Description: Change in concentration of circulating cytokines in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 84
Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- Treg Time: Day 84
Description: Change in soluble TNF receptor (sTNF-R) concentration in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- TNFR Time: Day 84
Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 28
Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 84
Secondary Outcomes
Description: Change from baseline in Clinical Dementia Rating Sum-of-Boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 28
Description: Change from baseline in Clinical Dementia Rating Sum-of-boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 84
Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score.
Measure: Cognitive Measures (RBANS) Time: Day 28
Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score
Measure: Cognitive Measures (RBANS) Time: Day 84
HPO Nodes
HP:0001268: Mental deterioration
Genes 478
PDGFRB HEPACAM DNAJC13 GLB1 HTT CHD2 SYNJ1 CLN6 FMR1 PSAP TOMM40 GBA SLC13A5 COX1 DAOA XPA TREM2 NOTCH3 PLAU ATP1A3 CNKSR2 AARS2 PINK1 SLC1A2 VPS13C TBP MAPT UCHL1 CHD2 PSEN1 TYMP SLC13A5 TRNC MAPT SCN8A EPM2A C19ORF12 SYNJ1 SNCA CP CHMP2B WWOX TRNK TRNL1 ND4 PDGFB TRAK1 APOL2 NR4A2 ERCC8 VPS13A LRRK2 HSD17B10 GIGYF2 WDR45 PRNP TRNQ DNMT1 SDHB TTPA GABRA2 SCO2 NDUFS2 GBA KMT2A PSEN2 PDGFRB SPG11 TLR3 TRPM7 SNCA GCH1 MAPT CACNA1B UBAP1 COX3 GRN FTL FMR1 TUBA4A HGSNAT ERCC2 ALDH18A1 VPS13C MAPT SQSTM1 PLP1 CUX2 FA2H APTX MAPT GBA ALDH18A1 ARSA TBP ROGDI MAPT GALC KCTD7 WFS1 CISD2 TRNQ APOE GBA MFSD8 PRNP PSEN2 JAM2 TBP HFE DCAF17 CLN3 QDPR NHLRC1 EEF1A2 TRNS1 KCNB1 UBQLN2 GNAS CHCHD10 ARSA TRNH SDHD HTRA1 ZFYVE26 HNRNPA2B1 NPC1 CTC1 C9ORF72 SLC2A3 CACNA1A MAPT TARDBP DARS2 CP DNMT1 RNF216 PSAP PLA2G6 SDHAF1 MAPT GABRG2 CLN5 XPR1 SGPL1 MYORG HNF1A SNCAIP LRRK2 PRKCG GRN TRNW ATP7B CLTC PRDM8 SUMF1 ADA2 PDGFRB IRF6 COMT ATXN2 GALC CHMP2B HTR2A NECAP1 SZT2 CLN6 DNMT1 AARS1 UBA5 ATP13A2 TRNS2 DMPK UCP2 NOS3 PSAP RBM28 A2M EPM2A YWHAG CSTB DNAJC5 COX1 CHMP2B WFS1 ATN1 ND5 PRKAR1A PARS2 JPH3 RBM28 TIMM8A RAB39B IDUA ND6 RRM2B MAPT GALC PTS KCNA2 LMNB1 COL18A1 APP ATXN7 PRNP FBXO7 ERCC4 PSEN1 NDP GRN PRDX1 ERCC6 SNCA FA2H NOTCH3 COX2 FGF12 NDUFAF3 TREM2 DHDDS RAB27A TIMM8A FTL GDAP2 PAH CTNS MAPT MECP2 ATP6 TMEM106B SNORD118 EIF4G1 AP5Z1 KCNA2 NBN HCN1 DNM1L ND6 RTN4R ADA2 ASAH1 TRNL1 SYNGAP1 CST3 ND1 OPA1 C9ORF72 HNRNPA2B1 DNM1 GBA DRD3 CTSD CHCHD10 HNRNPA1 TREX1 SCN3A ATXN10 NDUFB8 ATXN3 PSEN1 ADH1C GBA2 CHMP2B CHI3L1 PDGFB ACTL6B POLG CSF1R UBTF TRNF SURF1 ATP6V1A SYNJ1 ATXN8OS SNCA MAPT FUS PLA2G6 RRM2B MATR3 SNCA PANK2 ARSA PPP2R2B KCNC1 HTT PDE10A ND1 NRAS SPG11 RRM2B GALC BSCL2 SCN1A MTHFR MPO HIBCH SERPINI1 CPLX1 JPH3 NTRK2 PODXL ITM2B COX3 SPAST ABCD1 DISC2 C9ORF72 PRNP CLN8 COASY CSTB NPC2 LRRK2 SQSTM1 GBA CYTB NAGLU TRNV PPT1 RNF216 KCNJ11 HTRA1 RNASEH1 COL4A1 CYP27A1 TWNK ABCC8 PLEKHG4 APP AP2M1 MMACHC MBTPS2 TMEM106B ATP13A2 SPG21 ATN1 MFN2 SYN2 HEXA ATP6V0A2 PARK7 WDR45 DGUOK HTRA2 NOTCH2NLC TRNS2 CYFIP2 TBC1D24 TREM2 PRDM8 VPS35 HTT SYNJ1 TRNK AP3B2 GRN APOL4 PNPLA6 STXBP1 VCP TYROBP NUS1 TREM2 PSEN1 TYROBP TBK1 TREM2 PANK2 PINK1 MATR3 ATP6V1A SNCA BSCL2 GRN GRIN2D CSF1R TTR DNM1 COX2 MAPT TRNF SDHA VCP SORL1 ATXN2 TARDBP SCARB2 SLC6A1 APP GM2A TBK1 PRICKLE1 ATP13A2 APOE ROGDI POLG TK2 PSEN1 NDUFA6 PSEN1 APP PRKAR1B VCP ATP13A2 PRNP ITM2B ATP6 NHLRC1 SQSTM1 TINF2 CLN8 TBK1 ARV1 SMC1A ASAH1 ACTB HNF4A GBA APP HEXB CTSF CERS1 SQSTM1 TRNW TUBB4A APP PRNP C9ORF72 C19ORF12 CNTNAP2 SPG21 PRKN TIMMDC1 ATXN2 DCTN1 ND5 ABCA7 PPP3CA SNCB GABRB2 CUBN PRNP HLA-DQB1 SLC20A2 C9ORF72 TREX1 DCTN1 PPP2R2B VCP TMEM106B FA2H CFAP43 PSEN1 VCP TRNE GABRB3 GBA2 APP SCN1A TRNS1 ATXN7 ATP6V1E1 PDE11A SUMF1 PSAP GABRA5 VCP CHMP2B MAPT MAPK10 PLA2G6 MCOLN1 GBE1 ATP1A2 PRNP GLUD2 DNAJC6 HP:0100543: Cognitive impairment
Genes 871
PDGFRB FGFR3 CAMTA1 GLB1 CHD2 EDN3 SYNJ1 CLN6 FMR1 TOMM40 GBA SLC13A5 REEP2 COX1 DAOA TSFM XPA EPCAM SPTBN2 PLAU MEFV ATP1A3 PINK1 TBP COASY MAPT UCHL1 CHD2 TSC1 TYMP SLC13A5 SCN8A SCN8A RBM12 SNCA PEX1 GLA CHMP2B CCR1 WWOX TRNL1 ND4 PDGFB MLH3 MSH2 NUP133 APOL2 NR4A2 KCNQ3 VPS13A CFH GIGYF2 WDR45 DNMT1 AKT1 SDHB TRNL1 TTPA GBA PDGFRB XRCC4 CCDC78 PEX10 NUP107 MAPT CACNA1B CHRNG MAG KCNT1 HGSNAT C4A ERCC2 ALDH18A1 VPS13C SCN8A GABRG2 ABCA12 SQSTM1 PLP1 PEX12 CUX2 FA2H PNKP ALDH18A1 ARSA ROGDI MAPT WFS1 PTPN22 MFSD8 PSEN2 JAM2 DGUOK LZTFL1 DCAF17 SUFU SCN1B NHLRC1 EEF1A2 KCNB1 UBQLN2 GNAS SDHD HTRA1 NF2 FAS ZFYVE26 HNRNPA2B1 NPC1 CTC1 MYH3 SLC2A3 TARDBP DNMT1 SEC61A1 PSAP PLA2G6 TTC19 CLN5 POLG SMO HNF1A SNCAIP LRRK2 PRKCG TRNW ATP7B CLTC PRDM8 SUMF1 BAP1 B3GALNT2 TSC2 IRF6 SPG7 COMT CYP2U1 GALC CHMP2B STAT4 ALG9 DNMT1 IL23R PLAA ERAP1 UBA5 ATP13A2 DMPK NOS3 UQCRC2 RBM28 NPHP1 DNAJC5 TGM1 DOLK NKX6-2 MSH6 WFS1 PMS1 CFHR1 ATN1 POLG DCC OPA3 PRKAR1A TRNF SEC23B PARS2 RBM28 IRAK1 CHRM3 RAB39B DNAJC6 GSN ND6 AKT1 RRM2B MAPT GALC HLA-B SDHD POLG TTC8 LMNB1 COL18A1 DDB2 APP ATXN7 PLK4 ERCC4 PRKRA SLC2A1 PSEN1 SCN9A PRDX1 ERCC6 EIF2B1 PEX13 SNCA MEOX1 FA2H RPS20 PTEN NOTCH3 FGF12 COL5A2 NDUFAF3 TREM2 BBS10 ATR TRAIP SLC7A7 SCN2A TIMM8A FTL GDAP2 PAH MAPT EIF4G1 AP5Z1 KCNA2 NBN ERCC4 DNM1L ND6 ADA2 KRT6A GNAS TRNL1 MTO1 LIPN SCN1B ALG2 FGF14 CST3 CTSH ND1 SDR9C7 SDHD ITPR1 C9ORF72 HNRNPA2B1 DNM1 PIK3CA DRD3 EIF2B3 CHCHD10 TREX1 SCN3A GPC4 ATXN10 CEP152 NAGS NDUFB8 PSEN1 GBA2 CHMP2B PEX16 PMS2 POLG UBTF TRNF MAOA ERCC5 SYNJ1 ATXN8OS SNCA CYP4F22 FUS PLA2G6 SLC18A2 SNCA TBCK ARSA PIK3CA PPP2R2B PDE10A KRT81 ND1 SPG11 GALC SCN1A MTHFR IFT140 GJB6 JPH3 GRID2 PODXL SPAST ABCD1 SLC2A1 DISC2 C9ORF72 PEX19 FKTN GABRA1 BBS12 COASY BDNF LRRK2 GBA CYTB NAGLU PHOX2B PPT1 POMGNT1 RNF216 KCNJ11 TGFBR2 MARS2 COL4A1 HCRT PLEKHG4 APP MMACHC MBTPS2 TMEM106B ABCA7 SDHAF1 AFG3L2 IKBKG POMT1 POLG MFN2 VPS37A SEMA4A HEXA ATP6V0A2 TWNK POLG2 WDR45 DGUOK HTRA2 TMEM240 TRNS2 CYFIP2 EIF2B5 TBC1D24 PRDM8 VPS35 UBA1 CYP7B1 ATXN3 HTT SYNJ1 TRAF7 GMPPB CACNA1G GRN PIK3CA EPRS1 PNPLA6 TYROBP TBK1 TREM2 BAP1 CRLF1 PINK1 PEX11B BSCL2 GRN MAPT VCP VAMP1 BMPR1A CENPJ ERCC3 TARDBP SLC6A1 SMC3 TBK1 ERF PRICKLE1 MEN1 APOE ROGDI POLG GNPTAB PSEN1 ATRIP BBS5 NDUFA6 APP ATM PRKAR1B STAT4 PRNP B3GALNT2 ATP6 SQSTM1 SMC1A CENPJ ADAMTSL4 ACTB GBA ACSF3 SMARCB1 SPART SPG11 CERS1 SQSTM1 STXBP1 TUBB4A APP PRNP C9ORF72 ITGA7 CNTNAP2 MLH1 ATXN2 DCTN1 ALOX12B ABCA7 PRNP SLC20A2 ARL6IP6 RBBP8 PPP2R2B VCP TMEM106B CFAP43 AFG3L2 MTFMT APP SCN1A ATXN7 ATP6V1E1 KCNQ3 PDE11A SUMF1 PSAP GABRA5 C12ORF65 ATXN1 SMARCE1 C12ORF65 FAS MTOR POMT2 GM2A MCOLN1 KCND3 GBE1 ATP1A2 LAGE3 SLC30A9 PRNP CFHR3 DSTYK HEPACAM DNAJC13 HTT POMK TNFSF4 EIF2B4 PSAP HLA-DRB1 TREM2 OCRL NOTCH3 IL12A-AS1 CNKSR2 CTSK SCN1A AARS2 SLC1A2 VPS13C GABRG2 RRM2B UGT1A1 PSEN1 ADGRV1 SMC1A ERCC3 TRNC KMT2B MAPT GDNF EPM2A WDR4 C19ORF12 SYNJ1 CP ADD3 TRNK TRNK TRAK1 XPC HLA-DQB1 KLRC4 ERCC8 LRRK2 PEX6 HSD17B10 PRNP TRNQ COQ2 ATXN3 GABRA2 SCO2 NDUFS2 KMT2A PSEN2 GNAS SPG11 FGD1 TLR3 MYD88 TRPM7 GBE1 SNCA GCH1 GJC2 UBAP1 COX3 GRN FTL FMR1 TUBA4A MAPT ZNF365 ROBO3 KIF5A LAMA2 ATXN1 APTX MAPT DMD GBA LAMP2 SDHC SLC25A4 TRNS1 CCM2 TBP GALC KCTD7 CISD2 TRNQ APOE GBA SLC18A2 SPP1 PRNP TBP HFE PRRT2 CLN3 QDPR STUB1 TRNS1 CHCHD10 TWNK ARSA TRNH NAGS C9ORF72 CACNA1A MAPT DARS2 PEX14 CP PORCN RNR1 RNF216 IL12A AP5Z1 SDHAF1 MAPT C12ORF65 GABRG2 XPR1 SGPL1 KRT16 TSC1 METTL23 MYORG CEP120 GRN GCDH RNASEH1 ADA2 PDGFRB ATXN2 HTR2A NECAP1 SZT2 CLN6 KRT86 SLC25A15 AARS1 TRNS2 SPG7 OSGEP UCP2 PSAP ALG12 A2M EPM2A YWHAG CSTB COX1 CHMP2B ND5 NFIA TRNH JPH3 ITPR1 TIMM8A IDUA PCDH19 PTS KCNA2 GABRD TRNS2 SULT2B1 CYP2U1 PRNP FBXO7 NDP RMRP LTBP4 GRN TK2 GJB2 FBN1 ERCC2 FGF14 TUBB2B P2RY11 COX2 DHDDS RAB27A KCNQ2 CTNS DNAJC3 MECP2 ATP6 TMEM106B SNORD118 HCN1 PEX2 RTN4R SLC25A4 ASAH1 SCN2A SYNGAP1 BRAF OPA1 GBA ATP13A2 CTSD PNKP HNRNPA1 ABCA5 ATXN3 ADH1C SLC25A13 CHI3L1 PDGFB SIM1 ACTL6B GDF6 CSF1R CTNS TRNP SRCAP TRNQ SURF1 ATP6V1A CLCF1 NAGA MAPT GMPPB ATP1A3 RRM2B MATR3 PDCD10 DSG4 PANK2 KCNC1 HTT SCN9A PEX5 HSD17B4 NRAS RRM2B CTDP1 BSCL2 AUH MPO GDF3 ATXN3 HIBCH SERPINI1 CPLX1 SCN2A NTRK2 MYO1H PEX26 ITM2B COX3 PRNP CLN8 CSTB TTC37 NPC2 SQSTM1 TRNV NIPAL4 HTRA1 RNASEH1 CYP27A1 TWNK ABCC8 UBAC2 STARD7 AP2M1 POLG TPRKB ATP13A2 SPG21 PRKCG ATN1 GTPBP3 FKRP SYN2 PARK7 PCNT PDGFB NOTCH2NLC KCNQ2 TREM2 EIF2B2 ALOXE3 TRNK TSC2 AP3B2 TLR4 PANK2 APOL4 SOST KATNB1 STXBP1 VCP FAN1 NUS1 TREM2 CENPE PSEN1 TYROBP AASS PANK2 TWNK MATR3 ATP6V1A SNCA GNE TERT KLLN GRIN2D CSF1R TTR DNM1 ATG5 COX2 PANK2 TRNF SDHA XPA SORL1 ATXN2 GNAS SCARB2 GJC2 APP GM2A ATP13A2 TK2 KRT83 DARS2 IL10 FLNA SPR PSEN1 VCP ATP13A2 BRAF ITM2B IBA57 NHLRC1 HCN1 TINF2 CLN8 TBK1 LARGE1 VPS13A ARV1 RIN2 ASAH1 HNF4A APP COL5A1 HEXB CTSF LAMA1 TRNW VAMP1 SDCCAG8 WDR73 C19ORF12 BBIP1 MOG SPG21 SDHA PRKN TP53 KRT17 TP53RK KRAS TIMMDC1 SPTBN2 ND5 SPAST PPP3CA SNCB GABRB2 CUBN COL1A1 HLA-DQB1 STX1B SDHB MPDU1 C9ORF72 TREX1 DCTN1 SLC5A7 CLMP FA2H PSEN1 VCP TRNE PEX16 GABRB3 GBA2 USF3 TRNS1 TMEM240 STUB1 C9ORF72 ND5 GDF5 PEX3 POMT2 VCP PRNP CHMP2B GRID2 MAPT SCN1A MAPK10 KRIT1 KRT6B ECM1 PLA2G6 AIFM1 ALG13 PGM3 COL3A1 GLUD2 DNAJC6 Protein Mutations 0
SNP 0
Primary Outcomes
Description: Change in concentration of circulating cytokines in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response- cytokines Time: Day 84Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-Treg Time: Day 84Description: Change in soluble TNF receptor (sTNF-R) concentration in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-TNFR Time: Day 84Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in CSF from baseline.
Measure: CSF biomarkers of AD pathology-ATN Time: Day 84Description: Change in BCG on molecular markers of immune response (YKL40, and sTREM2) concentration from from Baseline.
Measure: CSF biomarkers of immune response. Time: Day 84Description: Change in concentration of circulating cytokines in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 28Description: Change in concentration of Treg number and proportion (relative to total CD4+ and CD8+ T cells) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-Treg Time: Day 28Description: Change in concentration of Soluble TNF receptor (sTNF-R) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-TNFR Time: Day 28Description: Change in concentration of circulating cytokines in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 84Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- Treg Time: Day 84Description: Change in soluble TNF receptor (sTNF-R) concentration in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- TNFR Time: Day 84Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 28Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 84Secondary Outcomes
Description: Change from baseline in Clinical Dementia Rating Sum-of-Boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 28Description: Change from baseline in Clinical Dementia Rating Sum-of-boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 84Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score.
Measure: Cognitive Measures (RBANS) Time: Day 28Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score
Measure: Cognitive Measures (RBANS) Time: Day 84