CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled
Drug / intervention
3 mg Donepezil hydrochloride +3 moredrug
Likely dose
3 mg Donepezil hydrochloridefrom 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.

Search/NCT00543855
NCT00543855Phase 2Completed
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Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

Eisai Co., Ltd.·interventional·Posted Oct 15, 2007·Updated Mar 8, 2013

In Brief

A Phase 2 clinical trial evaluating 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride, and 2 other interventions for Dementia With Lewy Bodies (DLB). Completed, enrolled 167 participants across 43 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety 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 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2007
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.7 years ago

Interventions

3 mg Donepezil hydrochloridedrug

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

5 mg Donepezil hydrochloridedrug

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

10 mg Donepezil hydrochloridedrug

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).

Placebodrug

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.