Back to resultsThe Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
Primary Purpose
Dementia With Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARICEPT
Sponsored by
About this trial
This is an interventional treatment trial for Dementia With Parkinson's Disease
Eligibility 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.
Sites / Locations
- Allgemeines Krankenhaus Barmbeck
- Parkinson Klinik Wolfach
- Belfast City Hospital
- Unit 20 Black Poo Technology Centerl
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00165815
Brief Title
The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eisai Limited
4. Oversight
5. Study Description
Brief Summary
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ARICEPT
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jina Schwartz
Organizational Affiliation
Eisai Limited
Official's Role
Study Director
Facility Information:
Facility Name
Allgemeines Krankenhaus Barmbeck
City
Hamburg
State/Province
Hambug
Country
Germany
Facility Name
Parkinson Klinik Wolfach
City
Wolfach
Country
Germany
Facility Name
Belfast City Hospital
City
Belfast
Country
Ireland
Facility Name
Unit 20 Black Poo Technology Centerl
City
Blackpool
Country
Ireland
12. IPD Sharing Statement
Learn more about this trial
The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
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