CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

GENUS device (Sham Settings)Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug355 Biological: mRNA-1273: 100 mcg Wiki 1.00
drug974 GENUS device (Active Settings) Wiki 1.00
drug356 Biological: mRNA-1273: 50 mcg Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D000544 Alzheimer Disease NIH 0.58

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002511 Alzheimer disease HPO 0.58

There is one clinical trial.

Clinical Trials

1 Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

In 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.

NCT04055376 Alzheimer Disease Alzheimer Dementia Device: GENUS device (Active Settings) Device: GENUS device (Sham Settings)
MeSH:Alzheimer Disease
HPO:Alzheimer disease

Primary Outcomes

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)

Other Outcomes

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)

Related HPO nodes (Using clinical trials)

HP:0002511: Alzheimer disease
Genes 13
APP A2M CACNA1G HFE PLAU APOE ABCA7 GATA1 APOE PSEN1 NOS3 PSEN2 MPO
Protein Mutations 5
E280A K56M P200T R199W R38H
SNP 10
rs10524523 rs11870474 rs2227902 rs3742376 rs3745274 rs3796529 rs4900442 rs6971 rs7157609 rs754203