The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
Sponsor
Eisai Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT00165815
Collaborator
(none)
4
35
Study Details
Study Description
Brief Summary
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date
:
Aug 1, 2002
Study Completion Date
:
Jul 1, 2005
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Allgemeines Krankenhaus Barmbeck | Hamburg | Hambug | Germany | |
| 2 | Parkinson Klinik Wolfach | Wolfach | Germany | ||
| 3 | Belfast City Hospital | Belfast | Ireland | ||
| 4 | Unit 20 Black Poo Technology Centerl | Blackpool | Ireland |
Sponsors and Collaborators
- Eisai Limited
Investigators
- Study Director: Jina Schwartz, Eisai Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00165815
Other Study ID Numbers:
- E2020-E044-316
First Posted:
Sep 14, 2005
Last Update Posted:
May 10, 2013
Last Verified:
Nov 1, 2005