Phase 3 Trial of Dextromethorphan-Bupropion for Agitation in Alzheimer Disease 

The first participant has been enrolled in the Addressing Dementia via Agitation-Centered Evaluation-2 (ADVANCE-2) trial (NCT03226522) of dextromethorphan-bupropion (AXS-05; Axsome Therapeutics, New York, NY), an investigational treatment for Alzheimer disease (AD) agitation.

The ADVANCE-2 trial is a randomized double-blind placebo-controlled multicenter trial to assess the efficacy and safety of dextromethorphan-bupropion for the treatment of AD agitation. Approximately 350 participants will be randomly assigned in a 1:1 ratio to receive dextromethorphan-bupropion or placebo for 5 weeks. Agitation will be assessed with Cohen-Mansfield Agitation Inventory (CMAI) measurement.

Dextromethorphan-bupropion has been granted Food and Drug Administration (FDA) breakthrough therapy designation for the treatment of agitation in AD.