A 30-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of E2020 in Patients with Alzheimer's Disease.

Eisai Clinical Trials

A 30-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of E2020 in Patients with Alzheimer’s Disease.

Protocol # E2020-A044-304

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: Not available

Trial Period: Jun 1994 - Jan 1997

Indication: Alzheimer's disease

Primary Endpoint: The primary efficacy endpoint was to evaluate the efficacy (primary efficacy parameters included ADAS-cog, CIBI-C Plus, IDDD, QOL, and CDR-SB) of two dose levels of E2020 (donepezil), versus Placebo, in patients with Alzheimer's Disease.

Population
Males and females (age 50 years and over)
Study Status
Completed
Study Phase
Phase 3
Countries
Australia, Canada, Europe, New Zealand, South Africa, United States See moreSee less

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

Burns A, Rossor M, Hecker J, Gauthier S, Petit H, Möller HJ, et al. The Effects of Donepezil in Alzheimer’s Disease – Results from a Multinational Trial. Dementia. 1999;10:237-44.

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