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

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

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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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