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CompletedPhase 2Results posted

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

167

actual

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoints

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

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-J081-431

NCT IDNCT00543855

Timeline

Milestones

Study first posted2007-10-15estimated

Study start2007-11 (month precision)

Primary completion2010-02actual (month precision)

Study completion2010-02actual (month precision)

Results first posted2013-02-18estimated

Last update posted2013-03-08estimated

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

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

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

Exclusion criteria

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

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

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

Participants with severe extrapyramidal disorders (Hoehn \& Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.

Endpoints (8)

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

Caregiver / quality of life

Global cognition

Behavior / neuropsychiatric

Global cognition

2 endpoints

Primary/protocol endpoint

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and every 4 weeks up to 12 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and every 4 weeks up to 12 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
3 mg Donepezil HydrochlorideBaselinen=33 Participants	20.1	4.2
Change from Baseline (LOCF)n=33 Participants	1.2	3.8
5 mg Donepezil HydrochlorideBaselinen=31 Participants	19.7	4.4
Change from Baseline (LOCF)n=31 Participants	3.5	3.2
10 mg Donepezil HydrochlorideBaselinen=33 Participants	19.7	4.5
Change from Baseline (LOCF)n=33 Participants	2.3	3.2
PlaceboBaselinen=30 Participants	18.2	4.8
Change from Baseline (LOCF)n=30 Participants	-0.6	2.7

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and every 4 weeks up to 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and every 4 weeks up to 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
3 mg Donepezil HydrochlorideBaselinen=33 Participants	20.9	13.1
Change from Baseline (LOCF)n=33 Participants	-4.3	21.5
5 mg Donepezil HydrochlorideBaselinen=31 Participants	14.2	8.4
Change from Baseline (LOCF)n=31 Participants	-5.9	6.5
10 mg Donepezil HydrochlorideBaselinen=33 Participants	19.1	11.8
Change from Baseline (LOCF)n=33 Participants	-10.2	12.0
PlaceboBaselinen=30 Participants	18.4	8.9
Change from Baseline (LOCF)n=30 Participants	-3.1	10.9

Caregiver / quality of life

4 endpoints

Primary/protocol endpoint

Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and week 12

threshold achievement, improvement

Primary/protocol endpoint

Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and Week 12

change from baseline, improvement

Primary/registry result

Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and week 12

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
3 mg Donepezil HydrochlorideMarked improvementn=33 Participants	3.6	-
Moderate Improvementn=33 Participants	17.9	-
Minimal Improvementn=33 Participants	50.0	-
No Changen=33 Participants	21.4	-
Minimal Worseningn=33 Participants	3.6	-
Moderate Worseningn=33 Participants	0	-
Marked Worseningn=33 Participants	3.6	-
5 mg Donepezil HydrochlorideMarked improvementn=31 Participants	17.9	-
Moderate Improvementn=31 Participants	17.9	-
Minimal Improvementn=31 Participants	35.7	-
No Changen=31 Participants	14.3	-
Minimal Worseningn=31 Participants	7.1	-
Moderate Worseningn=31 Participants	7.1	-
Marked Worseningn=31 Participants	0	-
10 mg Donepezil HydrochlorideMarked improvementn=33 Participants	3.8	-
Moderate Improvementn=33 Participants	11.5	-
Minimal Improvementn=33 Participants	50.0	-
No Changen=33 Participants	30.8	-
Minimal Worseningn=33 Participants	3.8	-
Moderate Worseningn=33 Participants	0	-
Marked Worseningn=33 Participants	0	-
PlaceboMarked improvementn=30 Participants	0	-
Moderate Improvementn=30 Participants	3.7	-
Minimal Improvementn=30 Participants	29.6	-
No Changen=30 Participants	18.5	-
Minimal Worseningn=30 Participants	37.0	-
Moderate Worseningn=30 Participants	11.1	-
Marked Worseningn=30 Participants	0	-

Primary/registry result

Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame:Baseline and Week 12

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
3 mg Donepezil HydrochlorideBaselinen=33 Participants	28.3	14.4
Change from Baseline (LOCF)n=33 Participants	-1.3	11.1
5 mg Donepezil HydrochlorideBaselinen=31 Participants	23.2	11.6
Change from Baseline (LOCF)n=31 Participants	-0.6	16.4
10 mg Donepezil HydrochlorideBaselinen=33 Participants	26.9	16.3
Change from Baseline (LOCF)n=33 Participants	-5.2	13.8
PlaceboBaselinen=30 Participants	22.3	9.8
Change from Baseline (LOCF)n=30 Participants	2.9	9.1

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.