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Could a pill boost brain function in Huntington's? new trial tests SAGE-718

NCT ID NCT05107128

Symptom relief Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested an experimental drug called SAGE-718 to see if it could improve cognitive function (like attention and processing speed) in people with Huntington's disease. 189 participants took either the drug or a placebo daily for a period of time. The main goal was to measure changes in a symbol-digit matching test. The trial has completed, and results will show whether SAGE-718 offers any benefit for thinking skills in Huntington's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-718 (oral capsules)
What this could lead to
If it works, this could point toward a treatment to help with thinking and memory problems in Huntington's disease.
What could go wrong
This is a Phase 2 trial, so results are still early. The drug may not improve cognition significantly, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

189 people

The number who actually took part.

Started

Jan 2022

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 greater than or equal to (≥) 36. 2. 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. 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.

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Huntington's disease

Contacts and locations

Locations

  • Sage Investigational Site

    Little Rock, Arkansas, 72205, United States

  • Sage Investigational Site

    La Jolla, California, 92037, United States

  • Sage Investigational Site

    Los Angeles, California, 90095, United States

  • Sage Investigational Site

    Sacramento, California, 95817, United States

  • Sage Investigational Site

    Englewood, Colorado, 80113, United States

  • Sage Investigational Site

    Washington D.C., District of Columbia, 20007, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33431, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33486, United States

  • Sage Investigational Site

    Tampa, Florida, 33612, United States

  • Sage Investigational Site

    Honolulu, Hawaii, 96817, United States

  • Sage Investigational Site

    Chicago, Illinois, 60611, United States

  • Sage Investigational Site

    Chicago, Illinois, 60612, United States

  • Sage Investigational Site

    Indianapolis, Indiana, 46202, United States

  • Sage Investigational Site

    Iowa City, Iowa, 52242, United States

  • Sage Investigational Site

    Kansas City, Kansas, 66160, United States

  • Sage Investigational Site

    Baltimore, Maryland, 21287, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02129, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02215, United States

  • Sage Investigational Site

    Farmington Hills, Michigan, 48334, United States

  • Sage Investigational Site

    Buffalo, New York, 14221, United States

  • Sage Investigational Site

    New York, New York, 10032, United States

  • Sage Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Sage Investigational Site

    Durham, North Carolina, 27705, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45219, United States

  • Sage Investigational Site

    Toledo, Ohio, 43614, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • Sage Investigational Site

    Charleston, South Carolina, 29425, United States

  • Sage Investigational Site

    Memphis, Tennessee, 38157, United States

  • Sage Investigational Site

    Nashville, Tennessee, 37212, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    Richmond, Virginia, 23298, United States

  • Sage Investigational Site

    Kirkland, Washington, 98034, United States

  • Sage Investigational Site

    Spokane, Washington, 99202, United States

  • Sage Investigational Site

    Madison, Wisconsin, 53792, United States

  • Sage Investigational Site

    Westmead, New South Wales, 2145, Australia

  • Sage Investigational Site

    Herston, Queensland, 4029, Australia

  • Sage Investigational Site

    Bethlehem, Victoria, 3162, Australia

  • Sage Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • Sage Investigational Site

    Halifax, Nova Scotia, B3S 1N2, Canada

  • Sage Investigational Site

    North York, Ontario, M2K 1E1, Canada

  • Sage Investigational Site

    Montreal, Quebec, H2X 0A9, Canada

  • Sage Investigational Site

    Tooting, London, SW17 0QT, United Kingdom

  • Sage Investigational Site

    Aberdeen, AB25 2ZA, United Kingdom

  • Sage Investigational Site

    Birmingham, B15 2FG, United Kingdom

  • Sage Investigational Site

    Cardiff, CF10 3AX, United Kingdom

  • Sage Investigational Site

    Leeds, LS7 4SA, United Kingdom

  • Sage Investigational Site

    Newcastle upon Tyne, NE6 4QD, United Kingdom

  • Sage Investigational Site

    Plymouth, PL6 8BT, United Kingdom

  • Sage Investigational Site

    Southampton, SO16 6YD, United Kingdom

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