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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:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165815
First received: September 13, 2005
Last updated: May 8, 2013
Last verified: November 2005

September 13, 2005
May 8, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Both
40 Years and older
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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