NCT05107128已完成2 期
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Change From Baseline in the SDMT
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet all the following criteria for HD at Screening (Days -28 to -2):
- •Genetically confirmed disease with huntingtin gene CAG expansion greater than or equal to (≥)
- •At screening, Unified Huntington's Disease Rating Scale (UHDRS)-Total Functional Capacity (TFC) score greater than (>) 6 and less than (<)13, suggesting no more than a moderate level of functional impairment.
- •No features of juvenile HD.
- •Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening indicating the presence of cognitive impairment.
- •Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.
- •Be ambulatory (use of assistance devices such as a walker or cane is acceptable, as is occasional use of wheelchair, as judged by the investigator. Individuals requiring a wheelchair on a regular basis are excluded), able to travel to the study center, and, as judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.
- •Completion of Huntington's Disease Cognitive Assessment Battery (HD-CAB) Trail Making-B Test in less than 240 seconds at Screening (Days -28 to -2).
排除标准
- •Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy, have participated in any HD investigational drug, biologic, or device trial within 180 days, or a non-HD drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer).
- •(Note: Participants with confirmation of enrollment in the placebo arm of these trials would not be excluded.)
- •Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive SAGE-718-matching placebo, orally, once daily (QD) for up to Day 84.
干预措施: Placebo (Drug)
SAGE-718
Experimental
Participants will receive SAGE-718, 1.2 milligrams (mg), capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84.
干预措施: SAGE-718 (Drug)
结局指标
主要结局
Change From Baseline in the SDMT
时间窗: Baseline, Day 84
The SDMT evaluates the tracking of cognitive function over time and for the early detection of cognitive impairment. The test assesses sustained attention, processing speed, visual scanning, and psychomotor speed, with the total score reflecting the number of correct pairings (out of 110 possible) completed within 90 seconds. Scores range from 0 to 110, with higher scores indicating better cognitive performance.
次要结局
- Change From Baseline in the Trail Making Test Part B(Baseline, Day 84)
- Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale(Baseline, Day 84)
- Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response)(Baseline, Day 84)
- Change From Baseline in the Paced Tapping Test (PTAP)(Baseline, Day 84)
- Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score(Baseline, Day 84)
- Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score(Baseline, Day 84)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to last follow-up visit (up to Day 112))
研究者
研究点 (1)
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