A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,315
- 试验地点
- 197
- 主要终点
- Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
研究概览
简要总结
This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
详细描述
This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.
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 AD
- •Ongoing donepezil therapy for AD
- •An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline
- •Hachinski Ischaemia score less than or equal to 4 at Screening.
- •If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
- •Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.
- •Subject has a reliable caregiver who is willing to report on subject's status throughout the study.
排除标准
- •Other Causes for Dementia
- •Diagnosis of vascular dementia
- •Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.
- •Confounding Medical Conditions
- •History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;
- •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
RVT-101
RVT-101 adjunct to 5 mg or 10 mg donepezil
干预措施: RVT-101 (Drug)
Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
干预措施: Placebo (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
时间窗: Baseline, 24 weeks
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24
时间窗: Baseline, 24 weeks
The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function
次要结局
- Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24(24 weeks)
- The Dependence Scale (DS) Score Change From Baseline to Week 24(Baseline, 24 weeks)
- Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24(Baseline and Week 24)
- ADAS-Cog-13 Score Change From Baseline to Week 24(Baseline, 24 weeks)
- Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma(Week 6, Week 12, Week 18, Week 24)