On 8 September, the biopharmaceutical company Axsome Therapeutics, which develops therapies for the management of central nervous system disorders, announced that it has started a Phase III clinical trial with AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. The first participant has been enrolled in the Phase III ADVANCE-2 trial of AXS-05. It is a randomised, double-blind, placebo-controlled and multicenter trial aiming to assess the efficacy and safety of AXS-05 for the treatment of agitation associated with AD. Approximately 350 patients will be enrolled to receive either AXS-05 or placebo for 5 weeks. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory (CMAI). AXS-05 has been granted US Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation. A Breakthrough therapy designation is a process to expedite the development and review of drugs for serious or life-threatening conditions.
Axsome Therapeutics initiates a new Phase III study for the treatment of AD agitation