A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

Eisai Clinical Trials

Protocol # E2020-J081-231

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: NCT00165659

Trial Period: Nov 2002 - May 2005

Indication: Alzheimer's disease

Primary Endpoint: 1. Primary Outcomes: Efficacy:

2. CIBIC plus*, SIB**

3. (*for overall evalution of clinical symtoms)

4. (**for cognitive function test)

5. Safety:

6. Adverse event, adverse drug reaction, vital sign, clinical laboratory parameter, electrocardiogram

Population
Males and females 50 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
Japan

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

Homma A, Imai Y, Tago H, Asada T, Shigeta M, Iwamoto T, et al. Donepezil treatment of patients with severe Alzheimer’s disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dement Geriatr Cogn Disord. 2008;25:399-407.

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