CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 302 enrolled
Drug / intervention
Donepezil hydrochloride +2 moredrug
Likely dose
Not stated in 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/NCT02660983
NCT02660983Phase 4Completed

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Donepezil Hydrochloride (E2020) in Patients With Dementia Associated With Cerebrovascular Disease

Eisai Co., Ltd.·interventional·Posted Jan 21, 2016·Updated Jan 10, 2020

In Brief

A Phase 4 clinical trial evaluating Donepezil hydrochloride and Donepezil matching placebo for Dementia Associated With Cerebrovascular Disease. Completed, enrolled 302 participants across 31 sites.

Detailed Summary

The primary objectives are to confirm that donepezil hydrochloride has superior efficacy compared with placebo in improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog), and to demonstrate that donepezil hydrochloride has superior efficacy compared with placebo in improving global function, as measured by Clinician's Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus), in patients with dementia associated with cerebrovascular disease (VaD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 21, 2016
Enrollment StartAug 5, 2013
Primary CompletionJul 13, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.4 years ago

Interventions

Donepezil hydrochloridedrug

Donepezil matching placebodrug

Donepezil hydrochloridedrug