A 15-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 15-week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of E2020 in Patients with Alzheimer’s Disease.

Protocol # E2020-A001-301

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: Not available

Trial Period: Dec 1993 - May 1995

Indication: Alzheimer's disease

Primary Endpoint: The primary efficacy endpoint was to evaluate the efficacy (primary efficacy parameters included ADAS-cog and CIBI-C Plus) of two oral dose levels of E2020, 5mg/day and 10mg/day, 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
United States

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Rogers SL, Doody RS, Mohs RC, Friedhoff LT. Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Arch Intern Med. 1998;158:1021-31.

Data Sharing

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Redacted documents are available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR