At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 142 enrolled
Drug / intervention
Donepezil 5 mg +2 moredrug
Likely dose
Donepezil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Donepezil 5 mg, Donepezil 10 mg, and 1 other intervention for Dementia With Lewy Bodies (DLB). Completed, enrolled 142 participants across 56 sites.
Detailed Summary
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia With Lewy Bodies (DLB)
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartFeb 2011
Primary CompletionMar 2013
Study CompletionApr 2013
TodayJul 2026
First PostedJan 17, 2011
Enrollment StartFeb 1, 2011
Primary CompletionMar 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.5 years ago
Interventions
Donepezil 5 mgdrug
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Donepezil 10 mgdrug
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Donepezil matched placebodrug