On 8 October, Sage Therapeutics, a biopharmaceutical company focused on delivering brain health therapies, announced top-line results from its Phase II LIGHTWAVE study evaluating dalzanemdor in Alzheimer’s disease (AD). The 12-week, randomised, double-blind, placebo-controlled trial included 174 participants from US and Puerto Rico, aged 50-80, with mild cognitive impairment (MCI) or mild dementia due to AD. The primary aim of the study was to assess changes in cognitive function using the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test. Top-line results showed that dalzanemdor failed to demonstrate statistically significant improvement in cognitive function compared to placebo after 12 weeks. The majority of treatment emergent adverse events were mild to moderate in severity. Additionally, no meaningful differences were observed in exploratory endpoints including the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA) total scores. As a result of these findings, Sage Therapeutics does not plan further clinical development of dalzanemdor in AD. The company continues to investigate the drug in other indications, including Huntington’s disease, with top-line results from the Phase II DIMENSION study expected later this year.
https://investor.sagerx.com/news-releases/news-release-details/sage-the…
