CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
E2020 +1 moredrug
Likely dose
E2020 23 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.

Search/NCT01276353
NCT01276353Phase 2Completed
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A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Eisai Inc.·interventional·Posted Jan 13, 2011·Updated Aug 8, 2014

In Brief

A Phase 2 clinical trial evaluating E2020 for Alzheimer's Type Dementia. Completed, enrolled 45 participants across 11 sites.

Detailed Summary

The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Type Dementia
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2011
Enrollment StartJan 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.5 years ago

Interventions

E2020drug

Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation

E2020drug

10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.