A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 11
- 主要终点
- Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.
研究概览
简要总结
This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.
详细描述
To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative gait and balance parameters.
Each subject will be randomized 1:1 to one of the following sequences:
Sequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late treatment period
Sequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late treatment period
Treatment A = RVT-101 35 mg once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).
- •Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements Subjects must be on stable background acetylcholinesterase inhibitor therapy
排除标准
- •History and/or evidence of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator) Any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
研究组 & 干预措施
Sequence AB
RVT-101 35 mg in Period II and Placebo in Period IV
干预措施: RVT-101 35 mg (Drug)
Sequence AB
RVT-101 35 mg in Period II and Placebo in Period IV
干预措施: Placebo (Drug)
Sequence BA
Placebo in Period II and RVT-101 35 mg in Period IV
干预措施: RVT-101 35 mg (Drug)
Sequence BA
Placebo in Period II and RVT-101 35 mg in Period IV
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.
时间窗: Baseline, 2 weeks
Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period.
Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.
时间窗: Baseline, 2 weeks
Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period
次要结局
未报告次要终点