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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00165815
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 10, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.

Condition or disease Intervention/treatment Phase
Dementia With Parkinson's Disease Drug: ARICEPT Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2002
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165815


Locations
Germany
Allgemeines Krankenhaus Barmbeck
Hamburg, Hambug, Germany
Parkinson Klinik Wolfach
Wolfach, 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

ClinicalTrials.gov Identifier: NCT00165815     History of Changes
Other Study ID Numbers: E2020-E044-316
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: November 2005

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents