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CompletedPhase 2Results posted

A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

160

actual

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoints

•Mini-Mental State Examination (MMSE)•Neuropsychiatric Inventory (NPI)

Identifiers

Registered as

Org study IDE2020-J081-432

NCT IDNCT00598650

Timeline

Milestones

Study first posted2008-01-22estimated

Study start2008-02 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Last update posted2014-09-03estimated

Results first posted2014-09-03estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

2. Patients who have completed Phase II double-blind study (E2020-J081-431).

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

Exclusion criteria

1. 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, and/or who underwent brain surgery causing unsolved deficiency.

2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.

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

5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Endpoints (4)

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

Behavior / neuropsychiatric

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline in Mini-mental State Examination (MMSE) Total

Time frame:Baseline, Week 52, and Week 52 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in Mini-mental State Examination (MMSE) Total

Time frame:Baseline, Week 52, and Week 52 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a Scale	Standard deviation
E2020Baselinen=104 Participants	20.9	5.1
Week 52n=104 Participants	0.3	3.7
Week 52 LOCFn=104 Participants	0.2	3.5
Placebo/E2020Baselinen=28 Participants	18.6	4.7
Week 52n=28 Participants	2	4.4
Week 52 LOCFn=28 Participants	1.7	4.4

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms

Time frame:Baseline, Week 52, and Week 52 LOCF

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms

Time frame:Baseline, Week 52, and Week 52 LOCF

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a Scale	Standard deviation
E2020Baselinen=104 Participants	13.1	16.8
Week 52n=104 Participants	-1.9	9.8
Week 52 LOCFn=104 Participants	-0.7	11.1
Placebo/E2020Baselinen=28 Participants	17.8	8.2
Week 52n=28 Participants	-4.1	10.1
Week 52 LOCFn=28 Participants	-4.3	9.7

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.