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EHDN 2022 | Phase II trial of SAGE-718 for the treatment of cognitive impairment in Huntington’s disease

SAGE-718 is a first-in-class oral positive allosteric modulator of the NMDA receptor, under investigation for the treatment of cognitive impairment in Huntington’s disease (HD). With early data suggesting that SAGE-718 was able to improve cognitive scores in patients with HD, the investigational agent was granted FDA Fast Track Designation and is now being studied in a new Phase II trial program and open label extension study. Aaron Koenig, MD, Sage Therapeutics, Cambridge, MA, introduces a placebo-controlled Phase II study was launched in early 2022 (DIMENSION; NCT05107128), which will enroll 178 patients with HD and mild-moderate cognitive impairment. Participants will receive study drug or placebo for 3 months and change from baseline in the Huntington’s Disease Cognitive Assessment Battery (HD-CAB) will be assessed as the primary endpoint. As well as examining the impact of SAGE-718 on cognitive function, investigators want to understand what this means for patients. Therefore, a second placebo-controlled study (SURVEYOR; NCT05358821) will assess how changes in cognitive performance are associated with measures of everyday functioning. An open-label extension study will also be conducted to investigate longer-term safety, tolerability, and efficacy. This interview took place during the European Huntington’s Disease Network 2022 Plenary Meeting.

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•Aaron Koenig is an employee of Sage Therapeutics, Inc., and may hold stock and/or stock options.
•The PERSPECTIVE Program is sponsored by Sage Therapeutics, Inc.
•SAGE‐718 is an investigational drug and is not approved by the US Food and Drug Administration or any other regulatory agency as safe and effective for any use.