drugset / Trial / NCT04797715

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

NCT04797715 ↗

Phase 3 Completed 178 enrolled Axsome Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Timeline

Start
2020-12-31
Primary completion
2022-11-21
Completion
2022-11-21

Outcome

Met primary endpoint

release “The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation” gcs-web.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AXS-05 Unknown — Oral

Indications