Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia
NCT01327859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 357
Last updated 2015-11-03
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.
Conditions
Interventions
- DRUG
-
Prior Donepezil 5mg
Received 5 mg donepezil once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.
- DRUG
-
Prior Donzepezil 10mg
Received 10 mg donepezil once daily during the preceding double-blind study, E2020-G000-316 . Received open-label 5 or 10 mg donepezil during the present study.
- DRUG
-
Prior Placebo
Received placebo once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Mark Harre · Eisai Limited
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2006-07-31
- Completion
- 2006-07-31
Countries
- United Kingdom
Study Locations
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