Completed
NCT Number: NCT00165815
The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.
Completed
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Allgemeines Krankenhaus Barmbeck, Hamburg, Hambug, Germany
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Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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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.
Sponsors and collaborators
Lead sponsor
Eisai Limited
Industry
Registry information
Important dates
- Study start
- 2002
- Study completion
- 2005
- First posted
- Sep 14, 2005
- Registry last updated
- May 10, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.