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AID

Completed

A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

Lead sponsor

Eisai Korea Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

2,231

actual

Study population

Alzheimer’s disease

Key I/E criterion

Primary endpoint

•Safety and tolerability due to an increase of Aricept

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 IDART-M082-601

NCT IDNCT02158910

Timeline

Milestones

Study first posted2014-06-09estimated

Study start2015-03actual (month precision)

Primary completion2016-06actual (month precision)

Study completion2016-06actual (month precision)

Last update posted2017-03-07actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Patients who admitted the reading and using of his/her biographical and medical data by word

2. Patients who maintained Aricept dosage for at least 3 months before involved in the study

Exclusion criteria

1. Hypersensitivity to the active substance or to any of the excipients

2. Breast feeding

3. Pregnancy

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.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.

Time frame:Up to 12 Weeks

event count, event

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.