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

  1. Meet all the following criteria for HD at Screening (Days -28 to -2): 1. Genetically confirmed disease with huntingtin gene CAG expansion ≥36. 2. At screening, UHDRS-Total Functional Capacity (TFC) score >6 and <13 suggesting no more than a moderate level of functional impairment. 3. No features of juvenile HD. 2. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening indicating the presence of cognitive impairment. 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. 5. 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).

Exclusion Criteria

  1. 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.) 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

ArmDescriptionAssigned Intervention
Experimental
SAGE-718 		Participants will receive SAGE-718, once daily for 84 days.
  • Drug: SAGE-718
    Oral capsules.
Placebo Comparator
Placebo 		Participants will receive placebo, once daily for 84 days.
  • Drug: Placebo
    SAGE-718-matching oral capsules.

Recruiting Locations

More Details

NCT ID
NCT05107128
Status
Completed
Sponsor
Sage Therapeutics