CompletedPhase 4Results posted

Neural Correlates In Mild Alzheimer's Disease

A Single Center Study To Examine Neural Correlates Of Cognition In Subjects With Mild Alzheimer's Disease After Three Months Of Open Label Donepezil HCl (Aricept® ) Treatment

Lead sponsor

Eisai Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-30

Primary endpoint

•Percent Change

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

Secondary IDA2501055Pfizer

Org study IDE2020-A001-416

NCT IDNCT00477659

Timeline

Milestones

Study first posted2007-05-24estimated

Study start2007-07-23actual

Primary completion2008-08-15actual

Study completion2008-08-15actual

Last update posted2021-11-10actual

Results first posted2021-11-10actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to 30 are allowed).

•Diagnostic evidence of Alzheimer's disease.

•Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed

Exclusion criteria

•Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.

Endpoints (10)

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Neuroimaging

Global cognition

4 endpoints

Secondary/protocol endpoint

Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score

Time frame:Baseline and Week 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score

Time frame:Baseline and Week 12

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezil HydrochlorideBaselinen=14 Participants	12.0	4.85
Change at Week 12n=14 Participants	-1.6	2.81

Secondary/registry result

Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezil HydrochlorideBaselinen=14 Participants	26.1	1.33
Change at Week 12n=14 Participants	0.1	2.70

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score

Time frame:Baseline and Week 12

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezil HydrochlorideBaselinen=14 Participants	13.1	3.71
Change at Week 12n=14 Participants	-0.3	2.70

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezil HydrochlorideBaselinen=14 Participants	9.2	10.00
Change at Week 12n=14 Participants	-3.4	11.25

Neuroimaging

2 endpoints

Primary/protocol endpoint

Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)

Time frame:Week 12

percent change from baseline, improvement

Primary/registry result

Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)

Time frame:Week 12

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	Standard deviation
Donepezil Hydrochloriden=14 Participants	7.47	17.23

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.