Axsome Therapeutics, Inc. announced a presentation of data from its ACCORD Phase 3 clinical trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, in patients with Alzheimer?s disease agitation (ADA), at the 16th Clinical Trials on Alzheimer?s Disease (CTAD) Conference, being held in Boston from Oct. 24-27. Results of the trial demonstrated rapid and sustained clinical response in patients with ADA during the open-label AXS-05 treatment phase.

During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo. AXS-05 was generally well-tolerated in the trial with no new safety signals identified. About the ACCORD Study: ACCORD (Assessing Clinical Outcomes in Alzheimer?s Disease Agitation) was a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate efficacy and safety of AXS-05 in patients with Alzheimer?s disease (AD) agitation.

Patients with a diagnosis of probable Alzheimer?s disease and clinically meaningful agitation associated with their disease were enrolled into a 9-week, open-label period, during which they were treated with AXS-05 and monitored for a sustained clinical response. Patients who experienced a sustained clinical response during the open-label treatment period were then randomized in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo treatment, in a double-blind fashion for up to 26 weeks. Treatment was continued until either a relapse of agitation symptoms or the end of the 26-week double-blind period, whichever occurred first.

The primary endpoint in the study was time from randomization to relapse of Alzheimer?s disease agitation calculated by the Kaplan-Meier estimates and the hazard ratio. The key secondary endpoint, to assess relapse prevention, was the percentage of patients who relapsed. The primary timepoint for open-label efficacy assessments was Week 5 and the key secondary timepoint was Week 2.