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Clinical Trial 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.


Clinical Trial Description

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04797715
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date December 31, 2020
Completion date November 21, 2022

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