The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.



Eligible Ages
Between 25 Years and 65 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. 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

  1. 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 2
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

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

Recruiting Locations

Sage Investigational Site
Little Rock, Arkansas 72205

Sage Investigational Site
La Jolla, California 92037

Sage Investigational Site
Los Angeles, California 90095

Sage Investigational Site
Sacramento, California 95817

Sage Investigational Site
Englewood, Colorado 80113

Sage Investigational Site
Washington, District of Columbia 20007

Sage Investigational Site
Boca Raton, Florida 33431

Sage Investigational Site
Tampa, Florida 33612

Sage Investigational Site
Honolulu, Hawaii 96817

Sage Investigational Site
Chicago, Illinois 60611

Sage Investigational Site
Chicago, Illinois 60612

Sage Investigational Site
Indianapolis, Indiana 46202

Sage Investigational Site
Iowa City, Iowa 52242

Sage Investigational Site
Kansas City, Kansas 66160

Sage Investigational Site
Baltimore, Maryland 21287

Sage Investigational Site
Boston, Massachusetts 02215

Sage Investigational Site
New York, New York 10032

Sage Investigational Site
Williamsville, New York 14221

Sage Investigational Site
Chapel Hill, North Carolina 27599

Sage Investigational Site
Durham, North Carolina 27705

Sage Investigational Site
Cincinnati, Ohio 45219

Sage Investigational Site
Toledo, Ohio 43614

Sage Investigational Site
Philadelphia, Pennsylvania 19107

Sage Investigational Site
Charleston, South Carolina 29425

Sage Investigational Site
Memphis, Tennessee 38157

Sage Investigational Site
Houston, Texas 77030

Sage Investigational Site
Richmond, Virginia 23298

Sage Investigational Site
Kirkland, Washington 98034

Sage Investigational Site
Spokane, Washington 99202

More Details

Sage Therapeutics

Study Contact

Grant Rutledge, PhD


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.