A 24-week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients with Dementia.

Eisai Clinical Trials

A 24-week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson’s Disease Patients with Dementia.

Protocol # E2020-E044-316

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: NCT00165815

Trial Period: Aug 2002 - Jul 2005

Indication: Dementia With Parkinson’s Disease

Primary Endpoint: 1. PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered.

Population
Males and females 40 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Australia, Belgium, Canada, France, Germany, Italy, New Zealand, Portugal, Russian Federation, South Africa, Spain, United Kingdom See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Dubois B et al. Donepezil in Parkinson’s disease dementia: A randomized, double-blind efficacy and safety study. Movement Disorders 2012; 27.10: 1230-1238. DOI: http://dx.doi.org/10.1002/mds.25098

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