Completed

Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

591

actual

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoints

•Mini-Mental State Examination (MMSE)•Mean Revised Hasegawa's Dementia Scale (HDS-R) score

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 IDART09T

NCT IDNCT02448784

Timeline

Milestones

Study start2015-04-20actual

Study first posted2015-05-19estimated

Primary completion2017-03-30actual

Study completion2017-03-30actual

Last update posted2018-07-11actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Naive participants diagnosed as DLB

Exclusion criteria

1. Participants with a history of donepezil hydrochloride product administration in the past

2. Participants who have already been registered in this surveillance

3. Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives

Endpoints (7)

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

Global cognition

Other (unclassified)

Safety / tolerability / PK

Global cognition

3 endpoints

Primary/protocol endpoint

Mean Mini-Mental State Examination (MMSE) score

Time frame:At Week 12

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Mean Mini-Mental State Examination (MMSE) score

Time frame:At Week 24

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Mean Mini-Mental State Examination (MMSE) score

Time frame:At Week 52

Mini-Mental State Examination (MMSE)

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)

Time frame:From Week 0 to Week 52

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame:At Week 12

descriptive

Primary/protocol endpoint/low confidence

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame:At Week 24

descriptive

Primary/protocol endpoint/low confidence

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame:At Week 52

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.