A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

Eisai Clinical Trials

A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer’s Disease Followed by a 12 Week Open-Label Extension Period

Protocol # E2020-A001-315

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: NCT00096473

Trial Period: Jan 2001 - Sep 2005

Indication: Alzheimer's disease

Primary Endpoint:
1. Assessments of global and cognitive function of Severe AD patients

Population
Males and females 50 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Australia, Canada, France, Ireland, United Kingdom, United States See moreSee less

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

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Publication reference citation

Black SE, Doody R, Li H, McRae T, Jambor KM, Xu Y, et al. Donepezil preserves cognition and global function in patients with severe Alzheimer’s disease. Neurology 2007;69:459-69.

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