Phase 4
Completed N=89
Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Genetic Risk for Alzheimer's Disease
Source: ClinicalTrials.gov NCT02087865 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: 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 — 44.68; 50.61; 45.57 100 * % Signal Change — p=0.273
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
44.68; 50.61; 45.57 | 0.273 |
| PRIMARY Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal |
19.91; 32.31; 19.38 | 0.001 sig |
| PRIMARY Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal |
24.9; 32.78; 26.73 | 0.115 |
| SECONDARY Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score |
52.86; 53.58; 51.41 | 0.941 |
| SECONDARY Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume |
3309.51; 3289.36; 3296.68 | 0.003 sig |
| SECONDARY Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume |
1810.88; 1756.92; 3363.62 | <0.001 sig |
| SECONDARY Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores |
21.41; 23.58; 23.28 | 0.005 sig |
| SECONDARY Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores |
44.17; 49.8; 47.73 | 0.011 sig |
Eligibility Criteria
Inclusion Criteria
- Normal general cognitive function
- High Risk Group Only: Family history (1st degree relative) of AD
- Low Risk Group Only: No family history (1st or 2nd degree relative) of AD
- Visual and auditory acuity adequate for neuropsychological testing
Exclusion Criteria
- Current or past history of
- neurological illnesses/conditions
- head trauma with significant loss of consciousness
- medical illnesses/conditions that may affect brain function
- severe psychiatric disorder
- substance abuse
- unstable or severe cardiovascular disease or asthmatic condition
- history of stroke or transient ischemic attack
Data sourced from ClinicalTrials.gov (NCT02087865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.