Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00165815 |
Date of registration:
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13/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
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Scientific title:
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Date of first enrolment:
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August 2002 |
Target sample size:
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Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00165815 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Ireland
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Contacts
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Name:
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Jina Schwartz |
Address:
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Telephone:
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Email:
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Affiliation:
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Eisai Limited |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia With Parkinson's Disease
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Intervention(s)
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Drug: ARICEPT
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Primary Outcome(s)
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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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Secondary ID(s)
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E2020-E044-316
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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