← Trials/Trial dossier/NCT02087865

CompletedPhase 4Results posted

Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease

Lead sponsor

The Cleveland Clinic

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-75

Primary endpoints

•BOLD Response•Left Hippocampus BOLD Signal•Right Hippocampus BOLD Signal

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID14-227

NCT IDNCT02087865

Timeline

Milestones

Study first posted2014-03-14estimated

Study start2014-05actual (month precision)

Primary completion2021-12-20actual

Study completion2021-12-20actual

Last update posted2023-08-30actual

Results first posted2023-08-30actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Memory

Other (unclassified)

Executive function / language

Memory

4 endpoints

Secondary/protocol endpoint

Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score

Time frame:Baseline and 24 Weeks

descriptive

Secondary/protocol endpoint

Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores

Time frame:Baseline and 24 Weeks

descriptive

Secondary/registry result

Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), Total number of correct items	Standard deviation
Donepezil HCLn=22 Participants	52.86	7.76
Placebon=26 Participants	53.58	9.71
Control Groupn=29 Participants	51.41	7.40

Mean Difference (Final Values)0.1595% CI-3.94 - 4.25p0.941ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Secondary/registry result

Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), Total number of correct items	Standard deviation
Donepezil HCLn=22 Participants	21.41	6.17
Placebon=26 Participants	23.58	5.84
Control Groupn=29 Participants	23.28	5.07

Mean Difference (Final Values)-3.3595% CI-5.65 - -1.04p0.005ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Executive function / language

2 endpoints

Secondary/protocol endpoint

Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores

Time frame:Baseline and 24 Weeks

event count, event

Secondary/registry result

Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores

Time frame:Baseline and 24 Weeks

event count, event

Posted result

Group	Value (mean), Total number of correct items	Standard deviation
Donepezil HCLn=12 Participants	44.17	7.96
Placebon=15 Participants	49.8	4.69
Control Groupn=22 Participants	47.73	4.87

Mean Difference (Final Values)-4.3095% CI-7.58 - -1.02p0.011ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Neuroimaging

6 endpoints

Primary/protocol endpoint

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

Time frame:Baseline and 24 Weeks

change from baseline, improvement

Primary/registry result

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

Time frame:Baseline and 24 Weeks

change from baseline, improvement

Posted result

Group	Value (mean), 100 * % Signal Change	Standard deviation
Donepezil HCLn=21 Participants	44.68	33.86
Placebon=26 Participants	50.61	23.46
Control Groupn=29 Participants	45.57	25.24

Mean Difference (Final Values)-8.2595% CI-23.12 - 6.63p0.273ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Secondary/protocol endpoint

Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume

Time frame:Baseline and 24 Weeks

descriptive

Secondary/protocol endpoint

Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume

Time frame:Baseline and 24 Weeks

descriptive

Secondary/registry result

Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), mm^3	Standard deviation
Donepezil HCLn=22 Participants	3309.51	300.08
Placebon=26 Participants	3289.36	260.1
Control Groupn=29 Participants	3296.68	312.89

Mean Difference (Final Values)46.3395% CI16.14 - 76.53p0.003ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Secondary/registry result

Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), mm^3	Standard deviation
Donepezil HCLn=22 Participants	1810.88	231.08
Placebon=26 Participants	1756.92	183.39
Control Groupn=29 Participants	3363.62	214.59

Mean Difference (Final Values)61.3695% CI35.25 - 87.46p<0.001ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame:Baseline and 24 Weeks

descriptive

Primary/protocol endpoint/low confidence

Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame:Baseline and 24 Weeks

descriptive

Primary/registry result/low confidence

Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), 100 * % Signal Change	Standard deviation
Donepezil HCLn=21 Participants	19.91	8.69
Placebon=26 Participants	32.31	16.62
Control Groupn=29 Participants	19.38	14.02

Mean Difference (Final Values)-13.4195% CI-21.09 - -5.73p0.001ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Primary/registry result/low confidence

Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal

Time frame:Baseline and 24 Weeks

descriptive

Posted result

Group	Value (mean), 100 * % Signal Change	Standard deviation
Donepezil HCLn=21 Participants	24.9	18.72
Placebon=26 Participants	32.78	20.57
Control Groupn=29 Participants	26.73	18.09

Median Difference (Final Values)-8.6095% CI-19.33 - 2.14p0.115ANCOVA

We are reporting the difference in mean between the Donepezil HCL and Placebo groups.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.