CompletedPhase 4Results posted

The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Lead sponsor

Eisai Korea Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

199

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Mini-Mental State Examination (MMSE)•CERAD-K

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 IDEKI-6-004

NCT IDNCT00381381

Timeline

Milestones

Study start2006-05-31actual

Study first posted2006-09-27estimated

Primary completion2008-08-31actual

Study completion2008-12-31actual

Results first posted2012-07-27estimated

Last update posted2022-01-04actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age: 60 - 90 years old.

2. CDR: 0.5 - 2.0.

3. Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.

4. Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.

5. NINCDS-ADRDA criteria: Probable AD

Exclusion criteria

1. Patients who have delusions and other conscious dysfunction.

2. Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.

3. Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.

4. Patients with severe cerebrovascular pathology.

5. Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.

6. Patients who have history of alcoholism or drug addiction.

7. Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.

Endpoints (8)

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

Behavior / neuropsychiatric

Global cognition

Executive function / language

Global cognition

2 endpoints

Primary/protocol endpoint

CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)

Time frame:26 weeks

Mini-Mental State Examination (MMSE)

event count, event

Primary/registry result

CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)

Time frame:26 weeks

Mini-Mental State Examination (MMSE)

event count, event

Posted result

Group	Value (mean), Units on Scale	Standard deviation
DonepezilVerbal Fluencyn=135 Participants	8.28	3.71
Boston Naming Testn=135 Participants	7.31	3.25
MMSE-KCn=135 Participants	17.86	5.25
Word List Memoryn=135 Participants	10.62	6.20
Construction Praxisn=135 Participants	7.61	2.71
Word List Recalln=135 Participants	1.98	1.99
Word List Recognitionn=135 Participants	4.64	3.24
Construction Recalln=135 Participants	2.11	2.71

Executive function / language

2 endpoints

Primary/protocol endpoint

CERAD-K

Time frame:26 weeks

descriptive

Primary/registry result

CERAD-K

Time frame:26 weeks

descriptive

Posted result

Group	Value (mean), Second	Standard deviation
DonepezilTrail making test An=135 Participants	206.64	126.94
Trail making test Bn=135 Participants	290.88	30.20

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Neuropsychiatry Inventory (NPI)

Time frame:26 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

GDS-K (Geriatric Depression Scale-Korean) Score After Treatment

Time frame:26 weeks

descriptive

Secondary/registry result

Neuropsychiatry Inventory (NPI)

Time frame:26 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), Units on Scale	Standard deviation
DonepezilDelusionsn=135 Participants	0.49	1.85
Hallucinationsn=135 Participants	0.12	0.69
Agitationn=135 Participants	0.54	1.56
Depressionn=135 Participants	0.76	1.82
Anxietyn=135 Participants	0.70	2.10
Euphorian=135 Participants	0.02	0.19
Apathyn=135 Participants	1.44	2.69
Disinhibitionn=135 Participants	0.28	1.19
Irritabilityn=135 Participants	0.67	1.93
Aberrant motor behaviorn=135 Participants	0.44	1.71
Night-time behaviorsn=135 Participants	0.40	1.68
Appetite and eating disordersn=135 Participants	0.43	1.46

Secondary/registry result

GDS-K (Geriatric Depression Scale-Korean) Score After Treatment

Time frame:26 weeks

descriptive

Posted result

Group	Value (mean), Units on Scale	Standard deviation
Donepeziln=135 Participants	11.69	6.42

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.