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CompletedPhase 4

A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

160

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 10-26

Primary endpoint

•Clinician's Interview-Based Impression of Change

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 IDE2020-J081-419

NCT IDNCT02345213

Timeline

Milestones

Study first posted2015-01-26estimated

Study start2015-03-01actual

Primary completion2017-05-15actual

Study completion2018-03-26actual

Last update posted2019-01-08actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Patients diagnosed with probable DLB according to the diagnostic criteria for DLB

2. Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution

3. Clinical Dementia Rating (CDR) score is greater than or equal to 0.5

4. Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)

2. Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period

3. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency

4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)

5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

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.

Caregiver / quality of life

1 endpoint

Primary/protocol endpoint

Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)

Time frame:Up to 12 weeks

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.