A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

  • End date
    Dec 11, 2024
  • participants needed
  • sponsor
    Sage Therapeutics
Updated on 11 May 2022
cognitive assessment


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
Treatment Placebo, SAGE-718
Clinical Study IdentifierNCT05107128
SponsorSage Therapeutics
Last Modified on11 May 2022


Yes No Not Sure

Inclusion Criteria

Meet all the following criteria for HD
Genetically confirmed disease with huntingtin gene CAG expansion ≥36
UHDRS-Total Functional Capacity (TFC) score >6 and <13\
No features of juvenile HD
Score <26 on the Montreal Cognitive Assessment (MoCA) at screening
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; individuals requiring a wheelchair 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 180 days or 5 half-lives (whichever is longer), unless the patient participated solely in the placebo arm of the study
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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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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