A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
研究概览
简要总结
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 99 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
E2020
Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg.
Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg.
干预措施: E2020 (Drug)
Placebo
Treatment period: Weeks 1-12 placebo
Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
时间窗: Up to 12 weeks
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse".
次要结局
未报告次要终点