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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
Asset
Donepezil
Listed sites
56
Recruiting sites
-
Enrollment
142
actual
Study population
Lewy body dementia
Key I/E criteria
•Dementia with Lewy bodies•MMSE 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange 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
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
| Group | Value (mean), Units on a scale | Standard deviation |
|---|---|---|
| Placebo - Confirmatory Phasen=44 Participants | 0.6 | 3.0 |
| Donepezil 5 mg - Confirmatory Phasen=43 Participants | 1.4 | 3.4 |
| Donepezil 10 mg - Confirmatory Phasen=49 Participants | 2.2 | 2.9 |
Behavior / neuropsychiatric
2 endpointsChange From Baseline in Neuropsychiatric Inventory (NPI-2) Score
Time frame:Week 12 for Confirmatory Phase
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
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
| Group | Value (mean), Units on a scale | Standard deviation |
|---|---|---|
| Placebo - Confirmatory Phasen=44 Participants | -2.0 | 4.2 |
| Donepezil 5 mg - Confirmatory Phasen=45 Participants | -1.7 | 4.3 |
| Donepezil 10 mg - Confirmatory Phasen=49 Participants | -2.9 | 4.7 |
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.
Registry references + supporting bibliography
- PMID25713600via DERIVED
- PMID25713599via DERIVED
Provenance
Sources
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.