The Efficacy, Tolerability and Safety of Donepezil (Aricept®) in Parkinson's Disease Patients With Dementia
This study has been completed.
Sponsor:
Eisai Limited
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165815
First received: September 13, 2005
Last updated: April 24, 2010
Last verified: November 2005
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial paroxysmal nonkinesigenic dyskinesia
Perry syndrome
U.S. FDA Resources
Further study details as provided by Eisai 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 | |
| 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00165815 History of Changes |
| Other Study ID Numbers: | E2020-E044-316 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 24, 2010 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Dementia Parkinson Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012
