Sage Therapeutics (Nasdaq: SAGE) announced topline results from the Phase 2 LIGHTWAVE Study of dalzanemdor (SAGE-718) in treating mild cognitive impairment and mild dementia in Alzheimer's Disease. The study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint, which was the WAIS-IV Coding Test score at Day 84.
Key points:
Dalzanemdor was generally well-tolerated with no new safety signals observed
The company does not plan further clinical development of dalzanemdor in Alzheimer's Disease
Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington's Disease is expected later this year
The study involved 174 randomized participants over 12 weeks
No meaningful differences were observed in exploratory endpoints such as RBANS total score or MoCA total score