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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug508 | BIIB091 Wiki | 0.45 |
| drug509 | BIIB107 Wiki | 0.32 |
| drug521 | BMS program Wiki | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug503 | BI 764198 - Formula A Wiki | 0.32 |
| drug4297 | Technology based social interactions Wiki | 0.32 |
| drug27 | 11C-ER176 Wiki | 0.32 |
| drug3231 | Placebo Oral Tablet Wiki | 0.32 |
| drug36 | 18F-MK-6240 Wiki | 0.32 |
| drug523 | BMS-986256 Wiki | 0.32 |
| drug34 | 18F-Florbetaben Wiki | 0.32 |
| drug506 | BI 764198 - Formula D Wiki | 0.32 |
| drug1734 | GENUS device (Sham Settings) Wiki | 0.32 |
| drug1763 | Gabapentin Enacarbil Wiki | 0.32 |
| drug2433 | Lumbar Puncture Wiki | 0.32 |
| drug2840 | No research related technology based social interactions Wiki | 0.32 |
| drug1733 | GENUS device (Active Settings) Wiki | 0.32 |
| drug517 | BLD-2660 Wiki | 0.32 |
| drug505 | BI 764198 - Formula C Wiki | 0.32 |
| drug4183 | Sumifilam (PTI-125), 100 mg tablet Wiki | 0.32 |
| drug2344 | Lifestyle medicine Wiki | 0.32 |
| drug510 | BIIB133 (Dapirolizumab pegol) Wiki | 0.32 |
| drug504 | BI 764198 - Formula B Wiki | 0.32 |
| drug119 | ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) Wiki | 0.32 |
| drug2317 | Lecanemab Wiki | 0.32 |
| drug513 | BIO101 Wiki | 0.32 |
| drug2619 | Milk of magnesia Wiki | 0.32 |
| drug3576 | Rapamycin Wiki | 0.22 |
| drug3561 | Rabeprazole Wiki | 0.22 |
| drug4472 | Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit Wiki | 0.22 |
| drug2229 | Itraconazole Wiki | 0.18 |
| drug502 | BI 764198 Wiki | 0.18 |
| drug3195 | Placebo Wiki | 0.08 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000544 | Alzheimer Disease NIH | 1.00 |
| D008569 | Memory Disorders NIH | 0.32 |
| D012148 | Restless Legs Syndrome NIH | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002354 | Memory impairment HPO | 0.32 |
| HP:0012452 | Restless legs HPO | 0.32 |
| HP:0001268 | Mental deterioration HPO | 0.21 |
Navigate: Correlations HPO
There are 10 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 monthsNighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
Description: The CMAI, modified for direct nighttime observation, will be used to collect objective data on nighttime agitation. Research Assistants (RAs) continuously observe the persons with dementia and record agitation behaviors every 5 minutes. The measure requires that the RAs first note whether the participant is behaviorally awake or asleep. Sleep is defined as a quiet state with eyes closed. Nighttime agitation behaviors are scored during wake. The RA will directly observe the participant when he, or she, is out of bed and record the observations using the CMAI. After the participant has gone to bed, the RA will observe him, or her, via a video camera placed in the bedroom and a small handheld monitor located in a hallway or room adjacent to the bedroom. The monitor will be shielded from view of non-research personnel when on, and turned off between 5-minute observations. The RAs will endeavor to be as sensitive as possible to the privacy of participants.
Measure: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation Time: Change from baseline at 2 and 8 weeksDescription: The same primary caregivers, if possible, on the evening and night shifts will each complete the CMAI Caregiver Version at baseline and 8 weeks.
Measure: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Caregiver Version. Time: Change from baseline at 2 and 8 weeksDescription: The mADCS-CGIC measures clinically meaningful change in the patient's condition relative to baseline on a 7-point Likert scale (markedly worse to markedly improved). The scale was modified to assess items specific to agitation, producing global ratings of change in agitation. This scale will be completed by the study Advanced Practice Nurse (APN) based on physical examination and interviews with nursing home caregivers and persons with dementia (if able).
Measure: Nighttime Agitation - Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC). Time: Change from baseline at 2 and 8 weeksDescription: The RA will continuously observe the participant in the evening and night and note every 5 minutes whether the participant is behaviorally awake or asleep. The sleep disturbance outcome will be collected at baseline and 8 weeks. Sleep and wake will be defined as percent of observations asleep or awake on Night 1, 5 pm-10 pm; and Night 2,10 pm-7am. The investigators have chosen to observe on 2 nights at different times to capture any night-to-night and time of night variability in sleep.
Measure: Sleep Disturbance - Direct Observation Time: Change from baseline at 2 and 8 weeksDescription: The BIT-RL consists of two parts: 1) Behavioral Indicators - direct observations for RLS behaviors, such as kicking or rubbing legs (8 items), and 2) Clinical Indicators - medical history or family informant interview (3 items), interviews with caregivers (2 items), and an interview with the resident with dementia (1 item). The research assistants (RAs) will continuously observe each participant for RLS behaviors for 20 minutes on one evening, between 6 pm and the usual bedtime. The study APN will assess for the Restless Legs Syndrome Clinical Indicators by reviewing the medical records, and interviewing family members, evening and night shift nurses, and participants. One item, leg discomfort (yes or no) requires an answer from the participant with dementia. The APN will assess for discomfort in legs in the evening during the interval when the evening nurses report that the participant with dementia is most restless.
Measure: Sleep Disturbance - Behavioral Indicators Test - Restless Legs (BIT-RL) Time: Change from baseline at 2 and 8 weeksDescription: The micro-mini actigraph is wristwatch-sized accelerometer worn on the wrist. In the investigators' previous studies with over 400 nursing home residents with dementia the investigators have "locked" the actigraph on the participant's wrist with a plastic tie that is comfortable to wear, yet difficult to remove. The actigraph is waterproof and can be left on during showers. Nighttime total sleep time is the main actigraphy sleep outcome. The investigators also will measure other sleep disturbance variables, including nighttime wake after sleep onset, sleep efficiency, sleep latency, and awakenings with the actigraph. Daytime will be defined as 7 am-7 pm, and nighttime will be defined as 7 pm- 7 am. Because the investigators have found that sleep varies in persons with dementia and multiple nights are often needed to obtain a more reliable measure, the investigators will measure sleep for 7 days and nights at baseline and 7 days and nights at 8 weeks.
Measure: Sleep Disturbance - Micro-Mini Motionlogger® Actigraph Time: Change from baseline at 2 and 8 weeksDescription: This is a single question measure: "How do you judge the risk that Mr. or Mrs. X will fall within 6 months - high or low?" asked at baseline, week 2, and week 8 of a nurse or aide with personal knowledge of the resident. If possible, the same nurse, aide, or caregiver will complete the GLORF each week.
Measure: Fall Risk and Cognition - Global Rating of Fall Risk (GLORF) Time: Change from baseline at 2 and 8 weeksDescription: The MMSE (range 0-30) is a 30-item cognitive screen measuring orientation, registration, short-term memory, attention/concentration, language and constructional capacity. The MMSE is a widely used screening test of cognition and takes about 10 minutes to administer to the person with dementia.
Measure: Mini-Mental State Examination (MMSE) Time: Change from baseline at 2 and 8 weeksDescription: The Physical Mobility Scale (PMS) is an 8-item performance-based scale routinely used to assess mobility of elderly persons living in long-term care facilities.
Measure: Physical Mobility Scale (PMS) Time: Change from baseline at 2 and 8 weeksThis study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.
Description: Here MRI means magnetic resonance imaging, ECG means electrocardiogram, and ADAs means antidrug antibodies.
Measure: Extension Phase: Number of Participants With Adverse Events (AEs), Clinically Significant Change From Baseline in Vital Signs Values, Abnormal MRI and ECG Values, Clinically Significant Findings in Laboratory Values, Positive ADAs, and any Suicidality Time: Month 18 up to Month 45In this trial, the safety and effect of daily exposure to light and sound stimulation on people with mild Alzheimer's Disease (AD) will be studied. COVID-19 Amendment: Due to the ongoing suspension of all in-person humans subject research across MIT in response to the COVID-19 pandemic, all enrolled participants who have not completed their 6-month visit will have their visit postponed to 9 months with a follow up at 18 months. Subjects who have completed their 6-month visit will still be instructed to continue and return at Month 12 for an evaluation. OPTIONAL: If the subject would like to come in for an evaluation between Month 9 and 18, we will invite participants to come on Month 12 to complete cognitive testing and EEG.
Description: Feasibility of daily at-home light and sound stimulation will be assessed by keeping track of the amount of time the GENUS device is used per day. The device will automatically log the start and end times of the device usage. The log data will be collected and assessed at the interim analysis time points (Month 1, Month 3) and later time points (Month 6 or 9 and Month 12 or 18).
Measure: Feasibility of at-home light and sound stimulation: amount of time of device usage per day Time: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)Description: Safety of daily at-home light and sound stimulation will be assessed by using a daily questionnaire that asks for any adverse effects of the stimulation. The daily questionnaires will be collected and assessed at the interim analysis time point (Month 1) and later time points (Month 6 or 9 and Month 12 or 18).
Measure: Safety of daily at-home light and sound stimulation: questionnaire Time: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)Description: The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assesses the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items ranges from 0 to 70 (lower score indicates lower cognitive impairment).
Measure: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) score Time: Baseline, Month 1, Month 3, Month 6 , and either Month 7 or Month 12 and Month 13. COVID-19 Amendment:Baseline, Month 1, Month 3, Month 9, and either Month 10 or Month 18 and Month 19.Description: The Mini Mental State Examination (MMSE) is an 11-item test that assesses the cognitive aspects of mental function. The items assess orientation, memory, attention, language, and visual construction. Total score of the 11 items ranges from 0 to 30 (lower score indicates greater cognitive impairment).
Measure: Change in Mini Mental State Examination (MMSE) score Time: Baseline, Month 1, Month 3, Month 6, and either Month 7 or Month 12 and Month 13. COVID-19 Amendment:Baseline, Month 1, Month 3, Month 9, and either Month 10 or Month 18 and Month 19.Description: Montreal Cognitive Assessment (MoCA) Test is a 30-question test that assesses the cognitive aspects of mental function. The questions assess visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. Total score ranges from 0 to 30 (lower score indicates greater cognitive impairment).
Measure: Change in Montreal Cognitive Assessment (MoCA) Test score Time: Baseline, Month 1, Month 3, Month 6, and either Month 7 or Month 12 and Month 13. COVID-19 Amendment:Baseline, Month 1, Month 3, Month 9, and either Month 10 or Month 18 and Month 19.Description: The National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery (UDS V3) assesses cognitive performance in dementia and mild cognitive impairment due to Alzheimer's Disease. The battery includes Craft Story 21 Recall (immediate and delayed), Benson Complex Figure Copy (immediate and delayed), Number Span Tests, Category Fluency, Trail Making Test A/B, Multilingual Naming Test (MINT), and the Verbal Fluency: Phonemic Test.
Measure: Change in National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery (UDS V3) score Time: Baseline and Month 6 (and Month 12 for subjects who choose to continue the daily device usage for 6 additional months). COVID-19 Amendment:Baseline and Month 9 (and Month 18 for subjects who continue the daily device usage for 9 additional months.Description: The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) evaluates cognitive function and is scored 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 (personal care is scored on a 4-point scale without a 0.5 rating available). The total score of the CDR-SB is obtained by summing each of the domain box scores, with scores ranging from 0 to 18 (higher score indicates greater cognitive impairment).
Measure: Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Time: Baseline, Month 1, Month 3, Month 6, and either Month 7 or Month 12 and Month 13. COVID-19 Amendment:Baseline, Month 1, Month 3, Month 9, and either Month 10 or Month 18 and Month 19.Description: The National Alzheimer's Coordinating Center Functional Assessment Scale (FAS) is a 10-item questionnaire that assesses whether subjects had a difficulty or needed help with activities of daily living in the past 4 weeks at the time of assessment.
Measure: Change in Functional Assessment Scale (FAS) Time: Baseline and Month 6 (and Month 12 for subjects who choose to continue the daily device usage for 6 additional months). COVID-19 Amendment:Baseline and Month 9 (and Month 18 for subjects who continue the daily device usage for 9 additional months.Description: The Geriatric Depression Scale (GDS): Short Form is a brief, 15-item questionnaire in which participants are asked to respond by answering "yes" or "no" in reference to how they felt over the past week. For each item, the answer indicating depression is given one point. Total score of the 15 items ranges from 0 to 15, with scores 0 - 4 considered normal, depending on age, education, and complaints; 5-8 indicating mild depression; 9-11 indicating moderate depression; and 12-15 indicating severe depression.
Measure: Change in Geriatric Depression Scale (GDS) Time: Baseline and Month 6 (and Month 12 for subjects who choose to continue the daily device usage for 6 additional months). COVID-19 Amendment:Baseline and Month 9 (and Month 18 for subjects who continue the daily device usage for 9 additional months.Description: The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a 12-item structured interview with a caregiver to assess behavioral disturbances. Each item consists of a screening question and sub-questions that are rated "no" (not present) or "yes" (present). Each item is then rated for severity on a 3-point scale including 1 (mild), 2 (Moderate) and 3 (Severe).
Measure: Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Time: Baseline and Month 6 (and Month 12 for subjects who choose to continue the daily device usage for 6 additional months). COVID-19 Amendment:Baseline and Month 9 (and Month 18 for subjects who continue the daily device usage for 9 additional months.Description: Change in blood biomarkers for Alzheimer's Disease, as assessed by measuring levels of amyloid, tau, and neurofilament light chain in the subject's blood sample.
Measure: Change in blood biomarkers for Alzheimer's Disease Time: Baseline and Month 6. COVID-19 Amendment: Baseline and Month 9.Description: Change in gene expression in peripheral white blood cells, as assessed by profiling the transcriptome of peripheral white blood cells via ribonucleic acid (RNA) sequencing. The peripheral white blood cells will be isolated and collected from the subject's blood sample.
Measure: Change in gene expression in peripheral white blood cells: ribonucleic acid (RNA) sequencing Time: Baseline and Month 6. COVID-19 Amendment: Baseline and Month 9.Description: Change in brain waves in the Delta, Theta, Alpha, Beta, and Gamma frequency bands, as assessed by analyzing the electroencephalography (EEG) signals recorded from the subject.
Measure: Change in electroencephalography (EEG) signals Time: Baseline, Month 3, Month 6, and either Month 7 or Month 12 and Month 13. COVID-19 Amendment: Baseline, Month 3, Month 9, and either Month 10 or Month 18 and Month 19.Description: Change in functional connectivity and structure of the brain, as assessed by analyzing the functional Magnetic Resonance Imaging (fMRI) signals recorded from the subject.
Measure: Change in functional Magnetic Resonance Imaging (fMRI) signals Time: Baseline, Month 3, and Month 6 (and Month 12 for subjects who choose to continue the daily device usage for 6 additional months). COVID-19 Amendment:Baseline, Month 3, Month 9 (and Month 18 for subjects who continue the daily device usage for 9 months).Description: Total sleep time, as assessed by analyzing the sleep data reported by an Actigraph activity monitor. The activity monitor will be attached to a wristband and worn by the subject through the study completion. The data from the activity monitor will be collected and assessed at the interim analysis time point (Month 1, Month 3) and later time points (Month 6 and either Month 7 or Month 12 and Month 13). COVID Amendment: Data will be collected once every 3-4 months via mail past Month 3 visit.
Measure: Total sleep time: Actigraph activity monitor Time: Over 7 months (or over 13 months for subjects continuing the daily device usage for 6 additional months). COVID-19 Amendment: Over 10 months (or over 19 months for subjects continuing the daily device usage for 9 additional months)Description: Sleep efficiency, as assessed by analyzing the sleep data reported by an Actigraph activity monitor. The activity monitor will be attached to a wristband and worn by the subject through the study completion. The data from the activity monitor will be collected and assessed at the interim analysis time points (Month 1, Month 3) and later time points (Month 6 and either Month 7 or Month 12 and Month 13). COVID Amendment: Data will be collected once every 3-4 months via mail past Month 3 visit.
Measure: Sleep efficiency: Actigraph activity monitor Time: Over 7 months (or over 13 months for subjects continuing the daily device usage for 6 additional months). COVID-19 Amendment: Over 10 months (or over 19 months for subjects continuing the daily device usage for 9 additional months)Description: Physical activity level, as assessed by analyzing the activity level data reported by an Actigraph activity monitor. The activity monitor will be attached to a wristband and worn by the subject through the study completion. The data from the activity monitor will be collected and assessed at the interim analysis time point (Month 1, Month 3) and later time points (Month 6 and either Month 7 or Month 12 and Month 13). COVID Amendment: Data will be collected once every 3-4 months via mail past Month 3 visit.
Measure: Physical activity level: Actigraph activity monitor Time: Over 7 months (or over 13 months for subjects continuing the daily device usage for 6 additional months). COVID-19 Amendment: Over 10 months (or over 19 months for subjects continuing the daily device usage for 9 additional months)An Open-label study for patients who completed the previous studies, PTI-125-02 or PTI-125-03. Additional new patients will be included for a total of 100 patients enrolled for this study.
Description: Safety and tolerability of Sumifilam (PTI-125)
Measure: Safety and Tolerability Time: Day 1 to Month 12Description: Biomarkers of AD pathology, neurodegeneration and neuroinflammation
Measure: Cerebrospinal fluid P-tau, neurofilament light chain, neurogranin, Total Tau, YKL-40, Abeta42 (pg/mL) Time: Screening to Month 12Description: Assess cognitive symptoms of dementia
Measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) Time: Day 1 to Month 12Description: Assess behavioral symptoms
Measure: Neuropsychiatric Index (NPI) Time: Day 1 to Month 12The 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 monthThis is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
Description: • PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF
Measure: Part A Non-compartmental PK parameters will be calculated and reported for ALZT-OP1a and ALZT-OP1b Time: • 2 DaysDescription: Evaluation AUC 0-∞ (area under the curve from 0 to infinity)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-∞ Time: 2 DaysDescription: Evaluation AUC 0-t (area under the curve from 0 to t hours where t is the last measured concentration)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-t Time: 2 DaysDescription: Evaluation AUCPLASMA/AUCCSF (ratio at 60 min, 120 min, 240 min, 360 min and 480 min)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUCPLASMA/AUCCSF Time: 2 DaysDescription: Evaluation CL/F (apparent total body clearance)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF CL/F Time: 2 DaysDescription: Evaluation Cmax (maximum plasma and CSF concentration observed)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Cmax Time: 2 DaysDescription: Evaluation t½ (half-life)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF t½ (half-life) Time: 2 DaysDescription: Evaluation tmax (sampling time at which Cmax occurred)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF tmax Time: 2 DaysDescription: Evaluation Vd/F (apparent volume of distribution)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Vd/F Time: 2 DaysDescription: Evaluation Beta Amyloid (Αβ-42)
Measure: Biomarker Beta Amyloid (Αβ-42) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Beta Amyloid (Αβ-40)
Measure: Biomarker Beta Amyloid (Αβ-40) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Beta Amyloid (Αβ-38)
Measure: Biomarker Beta Amyloid (Αβ-38) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Total Tau
Measure: Biomarker Total Tau Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Neurofilament light (Nf-L)
Measure: Biomarker Neurofilament light (Nf-L) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Glial Fibrillary Acidic Protein (GFAP)
Measure: Biomarker Glial Fibrillary Acidic Protein (GFAP) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation P-Tau (Thr 231)
Measure: Biomarker P-Tau (Thr 231) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Interferon-γ (IFN-γ)
Measure: Biomarker Interferon-γ (IFN-γ) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Tumor Necrosis Factor-α (TNF-α)
Measure: Biomarker Tumor Necrosis Factor-α (TNF-α) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Transforming Growth Factor-β1 (TGF-β1)
Measure: Biomarker Transforming Growth Factor-β1 (TGF-β1) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation CD33
Measure: Biomarker CD33 Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Triggering Receptor Expressed on Myeloid Cells-2 (TREM2)
Measure: Biomarker Triggering Receptor Expressed on Myeloid Cells-2 (TREM2) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Neurogranin
Measure: Biomarker Neurogranin Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Safety will be evaluated based on the number, type, and frequency of treatment emergent adverse events. They will be individually presented for all subjects in data listings, and summarized in tables by treatment group and by treatment assignment. The AEs will be summarized and reported collectively based on information obtained through physical examination, ECG, and laboratory findings captured after dosing was initiated.
Measure: Number of Treatment Emergent Adverse Events (TEAE) Time: 2 Days Part A and 60Days Part BThe purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease to participate. This includes patients with either: - Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties - Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties - Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties - The investigators are also enrolling older adults with normal visual, language, and memory function.
Description: The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
Measure: 11C-ER176 Standardized Uptake Value Ratio Time: Up to 24 monthsDescription: The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
Measure: 18F-MK6240 Standardized Uptake Value Ratio Time: Up to 24 monthsThe objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage Alzheimer's disease.
Description: The ADAS-Cog test is one of the most frequently used tests to measure cognition in clinical trials. Patients obtain scores of 0 to 70; higher scores indicate poorer performance.
Measure: Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsDescription: The CGIC test is often used in clinical trials of cognition. CGIC scores range from 1 (very much improved) through to 7 (very much worse).
Measure: Change from Baseline in Clinical Global Impression of Change (CGIC) score Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsDescription: The CDR-SOB is a commonly used dementia staging instrument. The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18 (lower is better).
Measure: Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsDescription: This test measures the type and relative preponderance of gut organisms at Rob Knight's lab at UCSD. To assess whether this intervention is associated with a systematic signal in the gut microbiome, he will use 16S rRNA amplicon sequencing, metagenomic sequencing, and untargeted mass spectrometry to analyze stool samples of these study participants. This will provide the relative proportion of organisms in the microbiome of these patients at each time interval.
Measure: Changes from baseline in the microbiome Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsDescription: The leukocyte telomere length assay from PBMCs will be performed in the laboratory of Dr. Elizabeth Blackburn at UCSF using the quantitative polymerase chain reaction method to measure telomere length relative to standard reference DNA, expressed as telomere to single-copy gene ratio (T/S).
Measure: Changes from baseline in telomere length Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsDescription: These are measures of inflammation (C-reactive protein in mg/L), lipids (total cholesterol, LDL-cholesterol, triglycerides in mg/dl), blood pressure (mm Hg), and weight (pounds).
Measure: Changes from baseline in biomarkers Time: At baseline and also after 20 weeks, 40 weeks, and 2 yearsThis 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 monthsAlphabetical 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