A 54-week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effects of Donepezil Hydrochloride (E2020) on Functional Outcomes in Patients with Alzheimer's Disease.

Eisai Clinical Trials

A 54-week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effects of Donepezil Hydrochloride (E2020) on Functional Outcomes in Patients with Alzheimer’s Disease.

Protocol # E2020-A001-312

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: Not available

Trial Period: Jul 1996 - Oct 1998

Indication: Alzheimer's disease

Primary Endpoint: The primary efficacy endpoint was to evaluate the efficacy (primary efficacy assessed on the basis of attrition from the study due to clinically evident functional decline) of donepezil HCI E2020, versus Placebo, in the management of Alzheimer's disease.

Population
Males and females (age 50 years and over)
Study Status
Completed
Study Phase
Phase 3
Countries
United States

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Mohs RC, Doody RS, Morris JC, Ieni JR, Rogers SL, Perdomo CA, et al. A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology. 2001;57:481-8.

Data Sharing

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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