The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.
Patients who complete all 24 weeks of the double-blind study E2020-E044-316 (NCT00165815) will be eligible for the open label extension study. Patients and caregiver/study partner will need to provide additional written informed consent to participate in the open label extension study. Safety and tolerability will be assessed after 4, 8 12, 24, 36 and 52 weeks. Cognition, Global Clinical Function, Activities of Daily Living, and Behaviour will be assessed after 24, and 52 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
357
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.
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.
Unnamed facility
Bath, Canterbury, United Kingdom
Safety and tolerability will primarily be assessed by recording of AEs
Time frame: 52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on cognition (ADAS)
Time frame: 52 weeks
To assess the efficacy of open-label donepezil (5-10mg/day) on cognition(MMSE)
Time frame: 52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on Global Function (CIBIC)
Time frame: 52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on ADLs (DAD and Schwab and England scales)
Time frame: 52 weeks
To assess the efficacy of open-label donepezil (5-10 mg/day) on behavior (NPI)
Time frame: 52 weeks
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