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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study examines the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease.
This 24-week study will examine the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be eligible for this study. Participants without a family history of AD will also be enrolled to serve as a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil HCL | Active Comparator | Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo for 24 weeks. |
|
| Control Group | No Intervention | Participants without a family history of AD will undergo the study evaluations but will not receive any study drug |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donepezil HCL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOLD Response From Baseline to 24 Weeks During Functional Magnetic Resonance Imaging - Left Posterior Cingulate BOLD Signal at 24 Weeks, Adjusting for Baseline Left Posterior Cingulate BOLD | Changes from baseline to 24 weeks follow-up fMRI - Left posterior cingulate BOLD signal at 24 weeks, adjusting for baseline left posterior cingulate BOLD signal. | Baseline and 24 Weeks |
| Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal | Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal. | Baseline and 24 Weeks |
| Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal | Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score | Rey Auditory Verbal Learning Test (RAVLT) (Sum of Trials 1-5) , adjusting for baseline RAVLT (Sum of Trials 1-5) score. The RAVLT total score has a minimum of 0 and a maximum of 75 correct items (15 per trial x 5 trials). A higher score means better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Rao, Ph.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Center for Brain Health | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil HCL | Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks. donepezil HCL |
| FG001 | Placebo | Participants will receive placebo for 24 weeks. Placebo |
| FG002 | Control Group | Participants without a family history of AD will undergo the study evaluations but will not receive any study drug |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number reflects the participants who completed the study in the respective study groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil HCL | Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks. donepezil HCL |
| BG001 | Placebo | Participants will receive placebo for 24 weeks. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BOLD Response From Baseline to 24 Weeks During Functional Magnetic Resonance Imaging - Left Posterior Cingulate BOLD Signal at 24 Weeks, Adjusting for Baseline Left Posterior Cingulate BOLD | Changes from baseline to 24 weeks follow-up fMRI - Left posterior cingulate BOLD signal at 24 weeks, adjusting for baseline left posterior cingulate BOLD signal. | Please note that the fMRI result of one subject was collected but could not be processed due to data quality issues. Hence, only 21 subjects in Donepezil HCL arm were analyzed. | Posted | Mean | Standard Deviation | 100 * % Signal Change | Baseline and 24 Weeks |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil HCL | Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks. donepezil HCL |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen M. Rao | Cleveland Clinic | 216 312-4168 | raos2@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2019 | Jun 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Baseline and 24 Weeks |
| Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume | Left hippocampus volume (MRI) at 24 weeks, adjusting for baseline left hippocampus volume | Baseline and 24 Weeks |
| Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume | Right hippocampus volume (MRI) at 24 weeks, adjusting for baseline right hippocampus volume | Baseline and 24 Weeks |
| Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores | Brief Visuospatial Memory Test (BVMT) learning scores at 24 weeks, adjusted for baseline BVMT learning scores. The BVMT-R total scare has a minimum of 0 and a maximum of 36 correct items (12 per trial x 3 trials). A higher score means better outcomes. | Baseline and 24 Weeks |
| Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores | Processing speed test (PST) at 24 weeks, adjusting for baseline PST scores. The PST has a minimum of 0 and no upper limit/maximum since it is the number of correct items in 2 minutes. A higher score means better outcome. | Baseline and 24 Weeks |
| Drug Non-compliance |
|
| Not analyzed due to anatomical abnormalities |
|
| BG002 | Control Group | Participants without a family history of AD will undergo the study evaluations but will not receive any study drug |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Participants will receive placebo for 24 weeks. Placebo |
| OG002 | Control Group | Participants without a family history of AD will undergo the study evaluations but will not receive any study drug |
|
|
|
| Primary | Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal | Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal. | Please note that the fMRI result of one subject was collected but could not be processed due to data quality issues. Hence, only 21 subjects in Donepezil HCL arm were analyzed. | Posted | Mean | Standard Deviation | 100 * % Signal Change | Baseline and 24 Weeks |
|
|
|
|
| Primary | Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal | Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal. | Please note that the fMRI result of one subject was collected but could not be processed due to data quality issues. Hence, only 21 subjects in Donepezil HCL arm were analyzed. | Posted | Mean | Standard Deviation | 100 * % Signal Change | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score | Rey Auditory Verbal Learning Test (RAVLT) (Sum of Trials 1-5) , adjusting for baseline RAVLT (Sum of Trials 1-5) score. The RAVLT total score has a minimum of 0 and a maximum of 75 correct items (15 per trial x 5 trials). A higher score means better outcomes. | Posted | Mean | Standard Deviation | Total number of correct items | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume | Left hippocampus volume (MRI) at 24 weeks, adjusting for baseline left hippocampus volume | Posted | Mean | Standard Deviation | mm^3 | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume | Right hippocampus volume (MRI) at 24 weeks, adjusting for baseline right hippocampus volume | Posted | Mean | Standard Deviation | mm^3 | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores | Brief Visuospatial Memory Test (BVMT) learning scores at 24 weeks, adjusted for baseline BVMT learning scores. The BVMT-R total scare has a minimum of 0 and a maximum of 36 correct items (12 per trial x 3 trials). A higher score means better outcomes. | Posted | Mean | Standard Deviation | Total number of correct items | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores | Processing speed test (PST) at 24 weeks, adjusting for baseline PST scores. The PST has a minimum of 0 and no upper limit/maximum since it is the number of correct items in 2 minutes. A higher score means better outcome. | Please note only those participants who had complete PST data were included in the analysis, which are 12 participants in Donepezil HCL group, 15 participants in Placebo group, and 22 participants in Control group. | Posted | Mean | Standard Deviation | Total number of correct items | Baseline and 24 Weeks |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 20 |
| 28 |
| EG001 | Placebo | Participants will receive placebo for 24 weeks. Placebo | 0 | 29 | 0 | 29 | 13 | 29 |
| EG002 | Control Group | Participants without a family history of AD will undergo the study evaluations but will not receive any study drug | 0 | 32 | 0 | 32 | 0 | 32 |
| Dizziness | General disorders | Non-systematic Assessment |
|
| Muscle cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Vivid dreams/Nightmares/Increased Dreams | General disorders | Non-systematic Assessment |
|
| Loose stool/Diarrhea/Increased Bowel Movement | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rumbling stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| Disturbed sleep | General disorders | Non-systematic Assessment |
|
| Persistent ringing in ears | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Recurrence of skin cancer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Decrease in appetite | General disorders | Non-systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment |
|
| Anxiety | General disorders | Non-systematic Assessment |
|
| Change in vision/Blurred vision | Eye disorders | Non-systematic Assessment |
|
| Mood changes/Mood swing | General disorders | Non-systematic Assessment |
|
| Rectal Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Frequent urge to urinate | Renal and urinary disorders | Non-systematic Assessment |
|
| Increased talkativeness | General disorders | Non-systematic Assessment |
|
| Lower than normal heart rate | Cardiac disorders | Non-systematic Assessment |
|
| Altered liver function tests | Hepatobiliary disorders | Non-systematic Assessment |
|
| Change in consistency of saliva | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Headache/Pain in head or neck area | General disorders | Non-systematic Assessment |
|
| Excessive thirts | General disorders | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Change in sexual intercourse or libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hand surgery under general anesthesia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Scrotal blisters | Reproductive system and breast disorders | Non-systematic Assessment |
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| Paresthesia in legs (numbness, tingling sensation) | Nervous system disorders | Non-systematic Assessment |
|
| Change in facial skin color (Darker skin in cheek area) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Increase in size of colloid cyst with early signs of hydrocephalus | Nervous system disorders | Non-systematic Assessment |
|
| Change in sweat/body smell | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eyebrows falling out | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |