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CompletedPhase 3Results posted

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

56

Recruiting sites

-

Enrollment

142

actual

Study population

Lewy body dementia

Key I/E criteria

Dementia with Lewy bodiesMMSE 10-26

Primary endpoints

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

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-J081-341
NCT IDNCT01278407

Timeline

Milestones

Study first posted2011-01-17estimated
Study start2011-02 (month precision)
Primary completion2013-03actual (month precision)
Study completion2013-04actual (month precision)
Results first posted2015-11-30estimated
Last update posted2023-06-29actual

Assets

Drug assets

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 consensus diagnostic criteria for DLB

2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution

3. Clinical Dementia Rating (CDR) score ≥ 0.5

4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion criteria

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

2. Patients who received anti-dementia drug therapy at the same institution

3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening

4. 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

5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)

6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

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
2
Behavior / neuropsychiatric
2

Global cognition

2 endpoints
Primary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Score

Time frame:Week 12 for Confirmatory Phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Score

Time frame:Week 12 for Confirmatory Phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Units on a scaleStandard deviation
Placebo - Confirmatory Phasen=44 Participants0.63.0
Donepezil 5 mg - Confirmatory Phasen=43 Participants1.43.4
Donepezil 10 mg - Confirmatory Phasen=49 Participants2.22.9

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score

Time frame:Week 12 for Confirmatory Phase

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score

Time frame:Week 12 for Confirmatory Phase

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), Units on a scaleStandard deviation
Placebo - Confirmatory Phasen=44 Participants-2.04.2
Donepezil 5 mg - Confirmatory Phasen=45 Participants-1.74.3
Donepezil 10 mg - Confirmatory Phasen=49 Participants-2.94.7

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.