Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1349 | Disulfiram Wiki | 0.31 |
| drug4711 | WALC-R Wiki | 0.22 |
| drug4281 | Table Setting Training Wiki | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4051 | Speed of Processing Training Wiki | 0.22 |
| drug1331 | Digital oximeter monitoring Wiki | 0.22 |
| drug4297 | Technology based social interactions Wiki | 0.22 |
| drug1359 | Dornase Alfa Inhalation Solution Wiki | 0.22 |
| drug1364 | Double-Blind NT-I7 Wiki | 0.22 |
| drug4474 | Transfer Package from CI Therapy Wiki | 0.22 |
| drug542 | Bacillus Calmette-Guerin (BCG) Wiki | 0.22 |
| drug1323 | Differential Leucocyte Count (CLDC) device and algorithm Wiki | 0.22 |
| drug3955 | Sham Wiki | 0.22 |
| drug2688 | Multi-tasking Training Wiki | 0.22 |
| drug1314 | Diet tracking and survey Wiki | 0.22 |
| drug1328 | Digital Health Online Platform Wiki | 0.22 |
| drug4707 | Volunteer of TIP-OA Program Wiki | 0.22 |
| drug523 | BMS-986256 Wiki | 0.22 |
| drug4380 | The use of the MentalPlusĀ® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 Wiki | 0.22 |
| drug1309 | Diagnostic test Covid-19 Wiki | 0.22 |
| drug839 | COVID-19 swap test PCR Wiki | 0.22 |
| drug2142 | Instrumental Activities of Daily Living Shaping Wiki | 0.22 |
| drug322 | Anthocyanins Wiki | 0.22 |
| drug1036 | Cognitive Stimulation Wiki | 0.22 |
| drug2840 | No research related technology based social interactions Wiki | 0.22 |
| drug2780 | Neurofeedback Wiki | 0.22 |
| drug1354 | Doctorgram Patient Kit Wiki | 0.22 |
| drug1305 | Diagnostic Test: serology test for COVID-19 Wiki | 0.22 |
| drug1312 | Dialectical Behavioral Therapy (DBT) Skills Wiki | 0.22 |
| drug4314 | Telehealth phone calls Wiki | 0.22 |
| drug2117 | Information leaflet Wiki | 0.22 |
| drug2687 | Multi-target Dietary Supplement (MTDS) Wiki | 0.22 |
| drug1793 | Goal Management Training (GMT) Wiki | 0.22 |
| drug1163 | Cooking Training Wiki | 0.22 |
| drug2779 | Neurocognitive assessment Wiki | 0.22 |
| drug510 | BIIB133 (Dapirolizumab pegol) Wiki | 0.22 |
| drug3170 | Physical Activity Wiki | 0.22 |
| drug1311 | Diagnostic test for detection of SARS-CoV-2 Wiki | 0.22 |
| drug4063 | Stakeholder of TIP-OA Program Wiki | 0.22 |
| drug1337 | Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care Wiki | 0.22 |
| drug2106 | Independent Living Program for Affordable Housing. Wiki | 0.22 |
| drug1338 | Direct Antigen Tests for COVID-19 Wiki | 0.22 |
| drug4323 | Telephone interview Wiki | 0.22 |
| drug1365 | Double-Blind Placebo Wiki | 0.22 |
| drug1327 | Digital Health Literacy Intervention Wiki | 0.22 |
| drug2619 | Milk of magnesia Wiki | 0.22 |
| drug1358 | Dornase Alfa Wiki | 0.22 |
| drug1319 | Dietary counselling on Food Groups according to IYC Feeding practices, WHO Wiki | 0.22 |
| drug3576 | Rapamycin Wiki | 0.15 |
| drug4472 | Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit Wiki | 0.15 |
| drug2007 | Hyperbaric oxygen Wiki | 0.15 |
| drug502 | BI 764198 Wiki | 0.13 |
| drug4593 | Usual Care Wiki | 0.07 |
| drug3195 | Placebo Wiki | 0.05 |
| drug4112 | Standard of care Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003072 | Cognition Disorders NIH | 0.33 |
| D008569 | Memory Disorders NIH | 0.22 |
| D003704 | Dementia NIH | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000544 | Alzheimer Disease NIH | 0.21 |
| D019965 | Neurocognitive Disorders NIH | 0.15 |
| D004827 | Epilepsy NIH | 0.15 |
| D012640 | Seizures NIH | 0.13 |
| D009422 | Nervous System Diseases NIH | 0.10 |
| D040921 | Stress Disorders, Traumatic NIH | 0.08 |
| D003324 | Coronary Artery Disease NIH | 0.07 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.07 |
| D020521 | Stroke NIH | 0.05 |
| D007249 | Inflammation NIH | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001268 | Mental deterioration HPO | 1.00 |
| HP:0002354 | Memory impairment HPO | 0.22 |
| HP:0000726 | Dementia HPO | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002511 | Alzheimer disease HPO | 0.21 |
| HP:0001250 | Seizure HPO | 0.10 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.07 |
| HP:0001297 | Stroke HPO | 0.05 |
Navigate: Correlations HPO
There are 21 clinical trials
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.
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 monthsDescription: 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 monthsDescription: 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 monthsThe aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.
Description: A composite measure from the CogTrack battery
Measure: Quality of episodic memory. Time: Baseline to 24 weeksDescription: CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.
Measure: Secondary endpoints from CogTrack Time: Baseline to 24 weeksDescription: Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.
Measure: Blood outcome analysis Time: Baseline to 24 weeksDescription: Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
Measure: Cardiovascular parameters Time: Baseline to 24 weeksDescription: Microbiota
Measure: Fecal analysis Time: Baseline to 24 weeksDescription: kyrinin
Measure: Urine analysis Time: Baseline to 24 weeksDescription: anthocyanin metabolites
Measure: CSF measurements Time: Baseline to 24 weeksDescription: Diagnosing and follow-up of cerebrovascular disease
Measure: MR-imaging/CT Time: Baseline to 24 weeksThis 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.
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 monthDescription: 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.
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 controlDescription: 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 investigators propose to conduct a 6-month 3-arm randomized controlled exercise trial among older adults to compare the efficacy of yoga with aerobic exercise and stretching-toning exercises on cognitive function, brain structure and function, cardiorespiratory fitness, functional fitness, and inflammatory and molecular markers. Using a single-blind, three arm randomized control trial, 168 older adults ages 55-79 will be assigned to either: a Hatha yoga group, an aerobic exercise group or an active stretching and toning control group. The groups will engage in hour-long group exercise sessions 3x/week. A comprehensive neurocognitive test battery, brain imaging, cardiovascular fitness test, and a blood draw will take place at baseline; end of the 6-month intervention, and at 12-month follow-up. The proposed work will examine the relationship between yoga training and improved cognitive functioning as well as identify neurobiological correlates as potential mechanisms of action through which yoga training exerts its effect on cognitive function. COVID-19 Precautions: Due to COVID-19, all exercise sessions will be conducted live via Zoom video-conferencing such that 1/3rd of the participants in each group will exercise in person with the research staff at UIUC campus once a week while the remaining 2/3rd will tune in via Zoom
Description: A comprehensive neuropsychological battery (part of the NIH toolbox) will be used that assesses different domains of cognitive function, including working memory, attention and executive function.
Measure: Change in cognitive function Time: Baseline, 6 months, 12 monthsDescription: MRI will be used to measure brain volume.
Measure: Change in brain structure Time: Baseline, 6 months, 12 monthsDescription: Functional MRI will be used to measure changes in brain activity during resting state.
Measure: Change in brain function Time: Baseline, 6 months, 12 monthsDescription: Brain-derived neurotrophic factor (BDNF) will be assessed through a blood serum analysis at each timepoint.
Measure: Changes in physiological biomarkers Time: Baseline, 6 months, 12 monthsDescription: The mediating role of cardiorespiratory fitness will be assessed by using a treadmill based graded exercise test designed to measure peak VO2 capacity
Measure: Changes in cardiovascular fitness Time: Baseline, 6 months, 12 monthsThe purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms
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 monthsDescription: 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 AndalucĆa (MĆ”laga) and CataluƱa (Tarrasa). In total 200 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=100) and TV-AssistDem (N=100) 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.
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 monthsDescription: 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 personĀ“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 AlzheimerĀ“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. ItĀ“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.
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 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: 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 interventionDescription: 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), as well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT group treatment, or a wait list condition.
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 Tower Test (part of Millisecond's online cognitive 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 Tower Test (part of Millisecond's online cognitive 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: ā¢ '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.
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 13Description: 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 13Description: This will be evaluated using the National Adult Reading Test. Participants will be asked to read form a list of 50 words and they will be scored based on whether or not they pronounce each word correctly.
Measure: Pre-morbid intelligence 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.
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 monthDescription: 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-GuƩrin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older adults.
Description: Change in concentration of circulating cytokines in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response- cytokines Time: Day 84Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-Ī²42/40, 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 concentration of circulating cytokines in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response- cytokines 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 concentration of ATN markers of AD pathophysiology (Amyloid-Ī²42/40, 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-Ī²42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 84Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score
Measure: Cognitive Measures (RBANS) Time: Day 84COVID-19 is having profound effects on older adults' due to social isolation measures which may negatively impact individuals' mental and physical health. Recently, a telephone program, the Telehealth Intervention Program for Older Adults (TIP-OA), was created. In this program, a volunteer is calling older adults (ageā„60) every week to have a friendly conversation. The objective of this study is to evaluate the effectiveness of this telephone program (TIP-OA) in reducing stress, improving the mental health of program users, and understand their experiences.
Description: Perceived Stress Scale (PSS) is a 14-item scale used to measure the degree to which life events are experienced and appraised as stressful. It asks respondents about how often they have felt certain ways in the past month, with responses ranging from 0 (never) to 4 (very often).
Measure: Perceived Stress Scale (PSS) Time: Change from Baseline to 4- and 8-weeks (15 minute assessment)Description: Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire used to diagnose depression and assess symptom severity. The questionnaire asks individuals how often in the last two weeks they have been bothered by problems like "feeling down, depressed, and hopeless" and "poor appetite or overeating." Scores for each question include 0 (not at all), 1 (several days), 2 (more than half of the days), and 3 (nearly every day).
Measure: Patient Health Questionnaire-9 (PHQ-9) Time: Change from Baseline to 4- and 8-weeks (15 minute assessment)Description: Generalized Anxiety Disorder-7 (GAD-7) is a 7-item scale that measures symptoms of anxiety present in the previous 2 weeks. Respondents can choose from a score of 0 (not at all sure), 1 (several days), 2 (over half the days), or 3 (nearly every day). Items include "Not being able to stop or control worrying" and "Being so restless that it's hard to sit still".
Measure: Generalized Anxiety Disorder-7 (GAD-7) Time: Change from Baseline to 4- and 8-weeks (15 minute assessment)Description: Fear of COVID-19 Scale is an 18-item scale measuring individuals' anxiety, fear and concern surrounding the COVID-19 pandemic. Items include: "Fear that I will be infected" and "Worry if I will be assigned to COVID wards if hospitalized" (34).
Measure: Fear of COVID-19 Scale Time: Change from Baseline to 4- and 8-weeks (15 minute assessment)Description: What are the roles, contributions, and challenges of volunteers in identifying the needs of program users and volunteers, providing access to services, and creating appropriate responses to identified needs for the success and efficacy of the program?
Measure: Interviews and Focus Groups with Volunteers Time: 8-weeks (2 hours)Description: What are the roles, contributions, and challenges of different stakeholders (e.g. community partners, program organizers, and clinicians) in identifying the needs of program users and volunteers, providing access to services, and creating appropriate responses to identified needs for the success and efficacy of the program?
Measure: Interviews and Focus Groups with Stakeholders Time: 8-weeks (2 hours)Description: What are the experiences and evaluation of the program users about their engagement with the TIP-OA? Has the program contributed in improving the health of the program users?
Measure: Interviews with Program Users Time: 8-weeks (2 hours)Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.
Description: Markers of inflammation impact - in relation to cerebrospinal fluid changes .
Measure: Blood biomarker changes of inflammation impact Time: Up to 3 monthsDescription: Markers of neurological impact - in relation to cerebrospinal fluid changes .
Measure: Blood biomarker changes of neurological impact Time: Up to 3 monthsDescription: Neurological impact in relation to cerebrospinal fluid changes
Measure: Neuroradiological changes Time: Up to 3 monthsDescription: in relation to cerebrospinal fluid changes/blood
Measure: Clinical course - Pulmonary gas exchange Time: Up to 3 monthsDescription: in relation to cerebrospinal fluid changes/blood
Measure: Clinical course - Lung function recording Time: Up to 3 monthsDescription: Patient ICU care data - in relation to cerebrospinal fluid changes
Measure: Patient characteristics Time: Up to 3 monthsAcute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.
Description: the Repeatable Battery for the Assessment of Neuropsychological Statusis (RBANS) is a neuropsychological test that provides information about 5 domains of cognition (1) immediate and (2) delayed memory, (3) attention, (4) visuospatial construction and (5) language) and provides a total score. It is a test that takes about 30 minutes and consists of twelve tests. These are: (1) List Learning, (2) Story Memory, (3) Figure Copy, (4) Line Orientation, (5) Picture Naming, (6) Semantic Fluency, (7) Digit Span, (8) Coding, (9) List Recall, (10) List Recognition, (11) Story Recall and (12) Figure Recall. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160
Measure: Neurocognitive impairment measured by RBANS Time: 6 months after admission at the intensive care unitDescription: Trail Making Test (TMT) is a test of executive functioning, visual search speed, scanning, speed of processing and mental flexibility. The total score is the time in seconds spent to complete each part.
Measure: Neurocognitive impairment measured by TMT Time: 6 months after admission at the intensive care unitDescription: The short IQCODE is a 16 question long questionnaire that assesses cognitive impairment in elderly patients. An informant is required to rate a patient's cognitive changes over a 10 year time period. Each question is scored from 1 (much improved over time) to 5 (much worse).
Measure: Neurocognitive impairment by the short IQCODE Time: 6 months after admission at the intensive care unitThis study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD).
Description: Development or worsening of medical symptoms or problems
Measure: Number of adverse events Time: Baseline to 12 monthsDescription: A comprehensive metabolic panel is used to measure change in glucose level
Measure: Change in glucose level Time: Baseline to 12 monthsDescription: A comprehensive metabolic panel is used to measure change in albumin level
Measure: Change in albumin Time: Baseline to 12 monthsDescription: A comprehensive metabolic panel is used to measure change in CO2
Measure: Change in carbon dioxide or bicarbonate (CO2) Time: Baseline to 12 monthsDescription: A comprehensive metabolic panel is used to measure change in calcium levels
Measure: Change in calcium Time: Baseline to 12 monthsDescription: A lumbar puncture and blood draw will be used to evaluate levels of study drug
Measure: Central nervous system penetration of rapamycin Time: Baseline and 12 monthsDescription: Cognition will be measured using the PACC5 scale. The PACC5 is a composite score comprised of measures of global cognition, memory, and executive function. The score reflects an averaged z-score. Scores range from -3 to +3 with higher scores indicating better cognitive performance.
Measure: Change in Cognition using preclinical Alzheimer's Cognitive Composite 5 (PACC5) Time: Baseline to 12 monthsDescription: CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. Domain scores are entered into an online algorithm and CDR-SOB score obtained by summing each of the domain box scores, ranging from 0 to 18. A lower score indicates better cognition.
Measure: Change in Cognition using Clinical Dementia Rating Scale sum of Boxes (CDR-SOB) Time: Baseline to 12 monthsDescription: Functional status will be measured using the functional assessment scale (FAS). The FAS is completed by a collateral source and assesses ability to complete instrumental activities of daily living. The scale has 10-items and responses range from 0-3. The total score is a sum of the individual items. The total score ranges from 0 to 30 with higher scores indicating more assistance needed.
Measure: Change in Functional status Time: Baseline to 12 monthsDescription: Symptoms will be evaluated using the Geriatric Depression Scale 15 Item (GDS-15). The GDS-15 is a self-report questionnaire with 15 items that have response options of 0 or 1. The total score is the sum of the individual items. The total score on the measure ranges between 0 to 15 with higher scores indicating more depressive symptoms.
Measure: Change in Neuropsychiatric symptoms Time: Baseline to 12 monthsDescription: Gait speed will be evaluated with an electronic gait mat
Measure: Change in Gait Speed Time: Baseline to 12 monthsDescription: Grip strength will be evaluated with a hand dynamometer
Measure: Change in Grip Strength Time: Baseline to 12 monthsDescription: Cerebrospinal fluid (CSF) levels of amyloid beta
Measure: Change in CSF amyloid beta Time: Baseline to 12 monthsDescription: Cerebral glucose metabolism is measured using fluorodeoxyglucose-Positron emission tomography (FDG-PET)
Measure: Change in cerebral glucose metabolism Time: Baseline to 12 monthsDescription: Measure of brain volumetry using MRI
Measure: Change in Brain Volumetry Time: Baseline to 12 monthsThis study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlusĀ® digital game of COVID-19 surviving patients after remission of symptoms.
Description: The evaluation of cognitive functions by the digital game MentalPlusĀ® (a scale of assessment and cognitive rehabilitation) will take place as follows: Scores range from 0 [Not improved] to 10 [fully improved] at cognitive functions memory, attention and executive after training with Scale. This game is already validated and standardized for the global population. The test takes 25 minutes to play, is playful and self-explanatory. It has twelve themes with cognitive functions: short and long-term memory; selective, alternate and concentrated attention, inhibitory control of executive function and visual perception. MentalPlusĀ® is completely randomized in its phases and themes. Therefore, the game can be used for cognitive assessment with a single theme (25 minutes of execution) or rehabilitation on 10 more themes and a final theme for reassessment of cognitive functions.
Measure: Assessment of cognitive functions after COVID-19 Time: 1 yearDescription: Rehabilitation of cognitive functions: executive, attention, memory, visual perception, language, after the remission of the symptoms of COVID-19. MentalPlusĀ® will be used in order to rehabilitate the cognitive functions of patients who have dysfunctions after COVID-19. The patient will play on alternate days (every other day) a theme of the game and will be rehabilitated through its 10 themes. At the end of these 10 themes, the patient will be reassessed by the last theme of the game, comprising a total of 12 themes. Each theme lasts for 25 minutes each.
Measure: Rehabilitation of cognitive functions after COVID-19 Time: 1 yearThis study is being performed to determine if a multi-ingredient dietary supplement is safe and easy to take by healthy older adults. Participants will be required to take one of three different doses of the dietary supplement for 90 consecutive days and complete wellness surveys and a daily log while taking the supplement. Participants will also provide blood samples at the start of the study, after 30 days, and at the end of the study which will help determine how participants respond to the supplement.
Description: Subjects are instructed to log any AEs that occur at any time during the study in the study journal. Participants will be contacted by phone after 7 days on the MTDS to assess any occurrence of AEs. Reported or observed AEs will be documented and followed to resolution.
Measure: Number of Participants With Treatment-Related Adverse Events (AE) as Assessed by CTCAE v5.0 Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Hematocrit (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Hemoglobin (g/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Erythrocytes (10^12/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Leukocytes (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Basophils (10^3/uL) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Basophils/Leukocytes (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Eosinophils (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Eosinophils/Leukocytes (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Lymphocytes (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Lymphocytes/Leukocytes (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Monocytes (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Monocytes/Leukocytes (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Neutrophils (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Neutrophils/Leukocytes (%) Time: out to 90 daysDescription: Safety Assessment in Hematology
Measure: Platelet Count (10^9/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Serum Glucose (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Sodium (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Potassium (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Calcium (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Chloride (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Urea (mmol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Creatinine (umol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Urate (umol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Albumin (g/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Alkaline Phosphatase (U/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Aspartate Phosphatase (U/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Alanine Transaminase (U/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Gamma Glutamyl Transpeptidase (U/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Total Bilirubin (umol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Direct Bilirubin (umol/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: Lactate Dehydrogenase (U/L) Time: out to 90 daysDescription: Safety Assessment in Serum Chemistry
Measure: High Sensitivity C-Reactive Protein (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin A (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin B1 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin B2 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin B3 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin B6 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin B12 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Biotin (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Folate (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Pantothenate (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin C (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin D3 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Vitamin K2 (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Magnesium (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Manganese (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Zinc (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Copper (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Alpha Lipoic Acid (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Glutamine (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Glutathione (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Carnitine (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Choline (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Inositol (mg/L) Time: out to 90 daysDescription: Plasma Micronutrient Levels
Measure: Coenzyme Q10 (mg/L) Time: out to 90 daysDescription: The SF-36 wellness questionnaire will be used to assess the health status of subjects. There are 36 individual questions which identify eight different facets of wellness. These have been described as physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These facets are further collapsed into physical and mental component summaries. The eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This questionnaire will be included in the study booklet given to each subject, and will be self administered.
Measure: 36-Item Short Form Survey (SF-36) Time: up to 90 daysThe purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test how often and how well you carry out tasks that rely on thinking in your daily life. You will be randomly assigned to receive the new therapy soon or about six months later. In other words, your treatment schedule will be determined by chance. The new therapy involves intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with rest periods interspersed as needed.
Description: The COPM is a widely used, transdiagnostic, individualized, structured interview that detects changes over time in a respondent's performance of five, self-selected activities of daily living (ADL). In this case, the instrument will be completed by a family caregiver and only assess instrumental ADL (IADL) with important cognitive components. Performance is rated using 10-point scale that ranges from 1-10 scale points. High scores reflect effective performance. The test score is the mean of the ratings of the five, self-selected IADL.
Measure: Canadian Occupation Performance Measure (COPM) Time: Change from Day 0 to Day 17Description: The INCA gathers a comprehensive record of participant changes in everyday Instrumental Activities of Daily Living (IADL) with important cognitive components that have been observed since the start of training. These can be reported by the participant (when possible), the caregiver, or other friends and family that have spent time with the participant. The test score is a count; it is the number of new and improved activities with important cognitive components that a participant has been observed to undertake in their daily life since beginning training. The range is 0 to infinite.
Measure: Improved and New Cognitive Ability (INCA) Time: Change from Day 0 to Day 17Description: The CTAL quantifies how well and independently participants complete activities of daily living (ADL) and instrumental ADL (IADL) outside the treatment setting. Twenty-two activities with important cognitive components are surveyed; each is rated by the family caregiver using 11-point scales. The How Well Scale is reported here. The range is 0-10 scale points; high scores reflect effective performance of the activities.
Measure: Cognitive Task Activity Log (CTAL) How Well Scale Time: Change from Day 0 to Day 17Description: The CTAL quantifies how well and independently participants complete activities of daily living (ADL) and instrumental ADL (IADL) outside the treatment setting. Twenty-two activities with important cognitive components are surveyed; each is rated by the family caregiver using 11 point scales. The Independence Scale is reported. The range is 0-10 scale points; high scores reflect performance of the activities without assistance from others.
Measure: Cognitive Task Activity Log (CTAL) Independence Scale Time: Change from Day 0 to Day 17Description: The Assessment of Motor & Process Skills is a widely used, transdiagonistic performance test. Patients will be asked to perform four typical IADL with important cognitive components in the lab. The tasks will be selected from a bank of 125 standardized, Rasch-calibrated tasks. Two sets of four tasks of similar difficulty and type will be assembled and presented in counterbalanced order to reduce the influence of any practice or other order effects. Performance will be videotaped and scored by independent raters masked to group assignment and testing order. The Process Scale score only will be calculated. Scores range from -5 to 5 logits. High scores reflect effective performance of the tasks.
Measure: Assessment of Motor and Process Skills (AMPS) Time: Change from Day 0 to Day 17Post-COVID-19 syndrome is an assembly of symptoms, following an infection with COVID-19. The syndrome is characterized by cognitive impairment, fatigue, sleep disorders, smell and taste disorders, pain and more. This long-term sequela can last for months after recovering from the virus, and no treatment is known to date. The aim of this study is to compare the effect of HBOT vs. Sham on post COVID-19 syndrome
Description: Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.
Measure: Cognitive health assessment (NeuroTrax) Time: Baseline, 2 monthsDescription: Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
Measure: Brain perfusion Time: Baseline, 2 monthsDescription: Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol
Measure: Brain microstructure Brain microstructure Time: Baseline, 2 monthsDescription: Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task
Measure: Brain function imaging Time: Baseline, 2 monthsDescription: Self-reported questionnaire covers the most common symptoms related to post-COVID19 disease
Measure: Post-COVID-19 symptom Time: Baseline, 2 monthsDescription: SF-36 questionnaire for self reporting qulity of life
Measure: Quality of Life SF-36 Time: Baseline, 2 monthsDescription: The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality
Measure: The Pittsburgh Sleep Quality Index PSQI Time: Baseline, 2 monthsDescription: The BSI-18 will be used to evaluate psychological distress. The BSI-18 is an 18 item self-report questionnaire which generates a summary scale, the global stress index (GSI), and three subscales: depression, anxiety, and somatization
Measure: The Brief Symptom Inventory - 18 (BSI-18) Time: Baseline, 2 monthsDescription: The BPI is a short, self-administered questionnaire. It contains 15 items, which include 2 multi-item scales measuring pain intensity and the impact of pain on functioning and well-being.
Measure: BPI - Brief pain inventory (short form) Time: Baseline, 2 monthsDescription: Static balance will be assessed by the Balance Error Scoring System (BESS); Dynamic balance and risk of falling will be assessed by the Timed Up and Go test (TUG) and 10-meter walk (10MW). Muscle function will be assessed by the sit to stand (STS) test for the leg strength and endurance and hand-held dynamometry (HHD) for the isometric grip strength. The sub-maximal aerobic capacity and endurance will be assessed by the 6-minute walk test (6MWT).
Measure: Neuro-physical evaluation Time: Baseline, 2 monthsDescription: The neurological exam will include tests of the cranial nerves, motor, sensory and cerebellar function and gait
Measure: Neurological evaluation Time: Baseline, 2 monthsDescription: Smell will be tested through smell identification kits to test for odour detection, discrimination and threshold. The kit is standardized for age and gender, and available in different languages (Sniffin' sticks). Taste will be tested on bilateral anterior and posterior parts of the tongue by four tastes: bitter, sour, salt and sweet ("The Taste Strip Test").
Measure: Smell and taste evaluations. Time: Baseline, 2 monthsDescription: The cardiopulmonary exercise test (CPET) is a non-invasive measurement of the cardiovascular system, respiratory system and muscles.
Measure: Cardiopulmonary exercise test Time: Baseline, 2 monthsDescription: Conventional echocardiography evaluation, linear, volumetric and Doppler measurements will be performed to assess cardiac functions.
Measure: Echocardiography Time: Baseline, 2 monthsDescription: Measurements of pulmonary functions will be performed using the MiniSpir testing apparatus.
Measure: Lung functions test Time: Baseline, 2 monthsDescription: Blood tests will evaluate immune system including cytokines, CRP and COVID-19 antibodies
Measure: Immune system Time: Baseline, 2 monthsThis study is an effectiveness trial investigating neurofeedback (NFB) in adults with PTSD (Post-Traumatic Stress Disorder). Participants will be randomly assigned to one of two treatment conditions - i) NFB, or ii) wait list. Due to the coronavirus pandemic, our study will, primarily, take place online (i.e., online assessment and treatment, with option of in-person fMRI, or functional magnetic resonance imaging, scans). NFB sessions will be conducted from home, with videoconferenced supervision by research staff. After study completion, individuals in the wait list condition will be offered the same NFB treatment.
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: 19 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 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 baseline to post-treatment assessment Time: 19 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 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports