Axsome: Phase 3 Meets Main Endpoint for Alzheimer's Agitation

 AXS-05 statistically significantly delayed time to relapse of Alzheimer’s disease agitation versus placebo (p=0.014, primary endpoint)

AXS-05 statistically significantly prevented relapse of Alzheimer’s disease agitation versus placebo (p=0.018, key secondary endpoint)

Statistically significant improvement in Alzheimer’s disease agitation, as measured by the CMAI total score, starting at Week 1 with open-label AXS-05 (p<0.001 vs baseline, all timepoints)

Improvement in Alzheimer’s disease agitation, assessed by the modified Alzheimer’s Disease Cooperative Study-CGIC scale, achieved by 66% of patients at 2 weeks and 86% at 5 weeks

Improvement in Alzheimer’s disease agitation, assessed by the PGI-C scale, achieved by 68% of patients at 2 weeks and 89% at 5 weeks

No treatments are currently approved for Alzheimer’s disease agitation

https://finance.yahoo.com/news/axsome-therapeutics-announces-axs-05-113500324.html