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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