Sage Therapeutics' Dalzanemdor Fails to Meet Primary Endpoint in Phase 2 Alzheimer's Trial
Key Insights
Sage Therapeutics' LIGHTWAVE Phase 2 study of dalzanemdor (SAGE-718) in mild cognitive impairment and mild dementia due to Alzheimer's disease (search) did not meet its primary endpoint.
The study did not show 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, with no new safety signals observed during the 12-week trial.
Sage Therapeutics has announced topline results from its Phase 2 LIGHTWAVE study, revealing that dalzanemdor (SAGE-718) did not meet its primary endpoint in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (search) (AD). The randomized, double-blind, placebo-controlled trial assessed the effects of dalzanemdor over 12 weeks but failed to demonstrate a statistically significant difference from baseline compared to placebo in the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84.
The LIGHTWAVE study involved 174 participants with MCI or mild dementia due to AD. While dalzanemdor was generally well-tolerated and no new safety signals were observed, analyses of exploratory endpoints, including the RBANS total score and MoCA total score, did not reveal any meaningful differences between the dalzanemdor-treated group and the placebo group.
Impact and Future Directions
"Alzheimer’s Disease is an incredibly complex and devastating condition, and people with related mild cognitive impairment and mild dementia need more treatment options," said Barry Greene, Chief Executive Officer of Sage Therapeutics. "While we are disappointed by the results of the LIGHTWAVE Study, we are grateful to participants, investigators, care partners, patient advocates and the Alzheimer’s community who helped make this important research possible. We hope our work and these findings help to inform future research."
Based on the LIGHTWAVE study results, Sage Therapeutics does not plan to continue clinical development of dalzanemdor in Alzheimer's disease (search). However, the company anticipates reporting topline data from the Phase 2 DIMENSION study of dalzanemdor in patients with cognitive impairment associated with Huntington’s Disease (search) later this year.
About Dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718) is described as a first-in-class investigational NMDA receptor (search) positive allosteric modulator (PAM). Sage Therapeutics is currently evaluating dalzanemdor in a Phase 2 study for cognitive impairment associated with Huntington’s Disease (search).