The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg) in Parkinson's disease with dementia compared to standard dose donepezil.
This study is open-label, prospective, randomized paralleled study. The investigators evaluate the efficacy of high-dose donepezil in patients with Parkinson's disease with dementia (PDD) who have taken standard donepezil (10mg) for 12 weeks. The participants, who sign the informed consent, are assigned into two groups randomly (high-dose donepezil group and standard donepezil group). All participants will be maintained the medication for 24 weeks and assessed cognitive function at 24 weeks. They will visit to clinic for 3 times (4, 12, 24 weeks) to assess cognitive function and adverse event. After the end of study, all participants were administrated by standard dose donepezil again.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
23mg/day for 24 weeks versus 10mg/day for 24 weeks
Inje university, busan paik hospital
Busan, South Korea
RECRUITINGKorean Mini-Mental State Examination-2 (MMSE-2)
scale for general cognitive function, We used Korean version of MMSE-2 from PAR company
Time frame: 24 weeks
Korean-Instrumental Activities of Daily Living
scales for activities daily living
Time frame: 24 weeks
Clinical dementia rating
scales for activities of daily living
Time frame: 24 weeks
Unified Parkinson's disease rating scale (UPDRS) part 3
scales for motor symptoms in Parkinson's disease
Time frame: 24 weeks
Modified Hoehn & Yahr stage
scales for status of Parkinson's disease
Time frame: 24 weeks
Schwab & England Activities of Daily Living
scales for activities daily living
Time frame: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory
scales for status of caregiver
Time frame: 24 weeks
Global Deterioration Scale
scales for activities of daily living
Time frame: 24 weeks
Korean-Montreal Cognitive Assessment
scales for cognition
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Time frame: 24 weeks
Semantic fluency to evaluate neuropsychiatric symptoms
scales for language
Time frame: 24 weeks