A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Change From Baseline in Mini-mental State Examination (MMSE) Total
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（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
1
干预措施: E2020 (Drug)
结局指标
主要结局
Change From Baseline in Mini-mental State Examination (MMSE) Total
时间窗: Baseline, Week 52, and Week 52 LOCF
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
时间窗: Baseline, Week 52, and Week 52 LOCF
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.
次要结局
未报告次要终点