The Efficacy, Tolerability and Safety of Donepezil (Aricept®) in Parkinson’s Disease Patients With Dementia

This study has been completed.

First Received: September 13, 2005 Last Updated: November 29, 2005 History of Changes

Sponsored by:	Eisai Limited
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00165815

Purpose

A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.

Condition	Intervention	Phase
Dementia With Parkinson's Disease	Drug: ARICEPT	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Dementia Parkinson's Disease

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

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.

Study Start Date:	August 2002
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both

Criteria

Patients with an established diagnosis of PD and dementia, who fulfill all of the inclusion criteria and none of the exclusion criteria listed below, will be eligible for enrolment into this study.

Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165815

Locations

Germany
Parkinson Klinik Wolfach
Wolfach, Germany
Germany, Hambug
Allgemeines Krankenhaus Barmbeck
Hamburg, Hambug, Germany
Ireland
Belfast City Hospital
Belfast, Ireland
Unit 20 Black Poo Technology Centerl
Blackpool, Ireland

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:

Jina Schwartz

Eisai Limited

More Information

No publications provided

Study ID Numbers:	E2020-E044-316
Study First Received:	September 13, 2005
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00165815 History of Changes
Health Authority:	European Union: European Medicines Agency

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders

Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Parkinson Disease
Movement Disorders
Mental Disorders
Donepezil
Parkinsonian Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases

Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Parkinson Disease
Movement Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Parkinsonian Disorders
Dementia
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009