Sage announces Phase 2 study of dalzanemdor did not meet primary endpoint

Sage Therapeutics announced topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of the investigational oral medicine dalzanemdor, or SAGE-718, in people with mild cognitive impairment or MCI, in Parkinson’s Disease, or PD. The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV, or WAIS-IV, Coding Test score at Day 42. Dalzanemdor was generally well-tolerated, and there were no new safety signals observed. “We are disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease,” said Barry Greene, CEO. The PRECEDENT Study was a double-blind, placebo-controlled Phase 2 study in people with MCI in PD. The study is designed to evaluate the safety and efficacy of dalzanemdor (SAGE-718) dosed over 6 weeks. A total of 86 participants were enrolled and randomized. The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV Coding Test score at Day 42.