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CompletedPhase 4

Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Lead sponsor

Eisai Korea Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

114

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-26

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 IDEKI-1002

NCT IDNCT00165724

Timeline

Milestones

Study start2004-06-30actual

Study first posted2005-09-14estimated

Primary completion2006-07-31actual

Study completion2006-12-31actual

Last update posted2021-12-30actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age90 Years

SexAll

Eligibility criteria

•Men or women aged 40 to 90

•Diagnosis of dementia according to DSM-IV

•Diagnosis of probable AD as defined by NINCDS-ADRDA criteria

•Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26

•Patients were generally healthy and ambulatory or ambulatory aided

•Patients did not take acetylcholinesterase inhibitor 4 weeks before screening

•Patients have useful MRI results 3 months before screening

Exclusion

•If they have evidence of TIA or major infarction

•Epilepsy patients

•If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse

•If they sensitive to acetylcholinesterase

•If they 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

ADAS-cog

ADAS-Cog

descriptive

Secondary/protocol endpoint

MMSE, CDR, GDS, NPI, ADL, SSDQ

Mini-Mental State Examination (MMSE)

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.