NCT02448784已完成不适用
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 591
- 主要终点
- Mean Mini-Mental State Examination (MMSE) score
研究概览
简要总结
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive participants diagnosed as DLB
排除标准
- •Participants with a history of donepezil hydrochloride product administration in the past
- •Participants who have already been registered in this surveillance
- •Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
研究组 & 干预措施
Participants with DLB
Participants with DLB who will receive donepezil hydrochloride per approved label.
干预措施: Donepezil Hydrochloride (Drug)
结局指标
主要结局
Mean Mini-Mental State Examination (MMSE) score
时间窗: At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
时间窗: At Week 52
次要结局
- Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)(From Week 0 to Week 52)
研究者
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未知
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