A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
Purpose
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.
Condition
- Huntington's Disease
Eligibility
- Eligible Ages
- Between 25 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Meet all the following criteria for HD: 1. Genetically confirmed disease with huntingtin gene CAG expansion ≥36. 2. UHDRS-Total Functional Capacity (TFC) score >6 and <13. 3. No features of juvenile HD. 2. Score <26 on the Montreal Cognitive Assessment (MoCA) at screening. 3. 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. 4. 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.
Exclusion Criteria
- Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have participated in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the patient participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides (ASOs) or an mRNA splicing modifier will be excluded. 2. 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SAGE-718 |
Participants will receive SAGE-718, once daily for 84 days. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo, once daily for 84 days. |
|
Recruiting Locations
Sage Investigational Site
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Sage Investigational Site
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Sage Investigational Site
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Sage Investigational Site
Charleston, South Carolina 29425
Charleston, South Carolina 29425
More Details
- NCT ID
- NCT05107128
- Status
- Recruiting
- Sponsor
- Sage Therapeutics