The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Korean Mini-Mental State Examination-2 (MMSE-2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
high dose donepezil (23mg)
Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)
干预措施: Donepezil (Drug)
standard dose denepezil (10mg)
Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)
干预措施: Donepezil (Drug)
结局指标
主要结局
Korean Mini-Mental State Examination-2 (MMSE-2)
时间窗: 24 weeks
scale for general cognitive function, We used Korean version of MMSE-2 from PAR company
次要结局
- Unified Parkinson's disease rating scale (UPDRS) part 3(24 weeks)
- Modified Hoehn & Yahr stage(24 weeks)
- Clinical dementia rating(24 weeks)
- Korean-Montreal Cognitive Assessment(24 weeks)
- Semantic fluency to evaluate neuropsychiatric symptoms(24 weeks)
- Schwab & England Activities of Daily Living(24 weeks)
- Caregiver-Administered Neuropsychiatric Inventory(24 weeks)
- Korean-Instrumental Activities of Daily Living(24 weeks)
- Global Deterioration Scale(24 weeks)
研究者
Sangjin Kim
Busan Paik Hospital, Inje University
Inje University