A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 65
- 主要终点
- Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
研究概览
简要总结
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
详细描述
The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.
The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject with probable DLB
- •Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
- •Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
- •Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
- •Patients currently receiving therapy for DLB are eligible for enrollment
排除标准
- •Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
- •Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
研究组 & 干预措施
RVT-101 35 mg
RVT-101 35 mg once daily
干预措施: RVT-101 35 mg (Drug)
RVT-101 70 mg
RVT-101 70 mg once daily
干预措施: RVT-101 70 mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
时间窗: Change from Baseline at 24 weeks
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
次要结局
- Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24(Change from Baseline at 24 weeks)
- Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24(Change from Baseline at 24 weeks)