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TerminatedPhase 4

Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Lead sponsor

Eisai Korea Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10

Primary endpoint

•ADAS-Cog

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 IDAS-019 (EKI-5-003)

NCT IDNCT00165750

Timeline

Milestones

Study start2005-03 (month precision)

Study first posted2005-09-14estimated

Primary completion2008-08actual (month precision)

Study completion2008-11actual (month precision)

Last update posted2013-11-20estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Over 60 years old.

2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.

3. MMSE score of 10~24, CDR of 1~2.

4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.

5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension

Exclusion criteria

1. Uncontrolled by donepezil because of adverse events.

2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.

3. If they have taken concomitant medication which were not allowed.

Endpoints (2)

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.

Global cognition

2 endpoints

Primary/protocol endpoint

MRI, ADAS-cog

Time frame:0, 12, 24 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus

Time frame:0, 12, 24 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.