A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Eisai Clinical Trials

A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer’s Disease

Protocol # E2020-C086-339

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: NCT01404169

Trial Period: Sep 2011 - Sep 2014

Indication: Alzheimer's disease

Primary Endpoint: 1. The change in the total Severe Impairment Battery (SIB) score at Week 24 [Time Frame: 24 weeks]

Population
Males and females 50 Years to 90 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
China

Results

CSR Synopsis

Download PDF

Lay Summary

No download available

Publication reference citation

Jia J, Wei C, Jia L, Tang Y, Liang J, Zhou A, et al. Efficacy and Safety of Donepezil in Chinese Patients with Severe Alzheimer’s Disease: A Randomized Controlled Trial. Journal of Alzheimer’s Disease. 2017;56:1495-504.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR