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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00165815
First Posted: September 14, 2005
Last Update Posted: May 10, 2013
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.
Information provided by:
Eisai Inc.
September 13, 2005
September 14, 2005
May 10, 2013
August 2002
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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.
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Complete list of historical versions of study NCT00165815 on ClinicalTrials.gov Archive Site
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The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
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A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Dementia With Parkinson's Disease
Drug: ARICEPT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2005
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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.

Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Germany,   Ireland
 
 
NCT00165815
E2020-E044-316
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Eisai Limited
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Study Director: Jina Schwartz Eisai Limited
Eisai Inc.
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP