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Completed

Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

722

Recruiting sites

Enrollment

10,238

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Mini-Mental State Examination (MMSE)

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 IDART05T

NCT IDNCT01129596

Timeline

Milestones

Study first posted2010-05-24estimated

Study start2010-06-10actual

Primary completion2015-09-25actual

Study completion2016-06-23actual

Last update posted2018-11-05actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Patients diagnosed with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients diagnosed with mild or moderate Alzheimer's Disease, applicable to FAST score 4 or 5

Exclusion criteria

Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.

Endpoints (1)

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

1 endpoint

Primary/protocol endpoint

The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation

Time frame:48 months(12 weeks and every 6 months)

Mini-Mental State Examination (MMSE)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Arai H, Hashimoto N, Sumitomo K, Takase T, Ishii M. Disease state changes and safety of long-term donepezil hydrochloride administration in patients with Alzheimer's disease: Japan-Great Outcome of Long-term trial with Donepezil (J-GOLD). Psychogeriatrics. 2018 Sep;18(5):402-411. doi: 10.1111/psyg.12340. Epub 2018 Jul 11.
PMID29993162via BACKGROUND

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.