A 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With Dementia
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
357
1 country
1
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2006
Actual (reported)Study Completion
July 2006
Actual (reported)The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
July 2006
Actual (reported)July 2006
Actual (reported)March 30, 2011
Actual (reported)April 4, 2011
Actual (reported)Safety and tolerability will primarily be assessed by recording of AEs
52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on cognition (ADAS)
52 weeks
To assess the efficacy of open-label donepezil (5-10mg/day) on cognition(MMSE)
52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on Global Function (CIBIC)
52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on ADLs (DAD and Schwab and England scales)
52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on behavior (NPI)
52 weeks
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.
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.
Bath, Canterbury, BA2 5RP, United Kingdom
Mark Harre
Eisai Limited
357 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2011
First Posted
April 4, 2011
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2006
Actual (reported)Study Completion
July 2006
Actual (reported)Last Updated
November 3, 2015
Record last verified: 2015-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: