Dalzanemdor (SAGE 718) did not demonstrate a statistically significant difference from baseline on the primary endpoint in the phase II LIGHTWAVE study for the treatment of mild cognitive impairment and mild dementia in alzheimer’s disease

The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the primary outcome measure of the study.

Based on these data, the Company does not plan further clinical development of dalzanemdor in AD. The Company expects to report topline data from the Phase II DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington’s Disease later this year.

LIGHTWAVE Study Results
The LIGHTWAVE study was a 12-week, Phase II randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with MCI or mild dementia due to AD. A total of 174 participants were randomized.  The LIGHTWAVE study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the WAIS-IV Coding Test score at Day 84. Dalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment emergent adverse events were mild to moderate in severity. Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as RBANS total score or MoCA total score.

Dalzanemdor (SAGE 718) is a first-in-class investigational NMDA receptor positive allosteric modulator (PAM). Sage has an ongoing placebo-controlled Phase II study evaluating dalzanemdor in cognitive impairment associated with Huntington’s Disease.