On 27 April, the company Axsome Therapeutics, which develops therapies for the management of central nervous system disorders, reported top-line results of its ADVANCE-1 trial of AXS-05. The Phase II/III ADVANCE-1 study was designed as a multicenter, randomised, double-blind and controlled trial, enrolling 366 US participants with agitation associated with Alzheimer’s disease (AD).
The company announced that the ADVANCE-1 trial met its primary endpoint by demonstrating a statistically significant improvement in AD agitation at week 5. The improvement was determined using the Cohen Mansfield Agitation Inventory (CMAI) total score. Results showed a statistically significant mean reduction from baseline of 48% for AXS-05 and 38% for placebo. In addition, AXS-05 was reported to have rapidly and significantly improved agitation symptoms at week 3 in people with AD starting to receive the full dosing of AXS-05 at week 2 as compared to placebo. AXS-05 was well tolerated. The most commonly reported adverse events were somnolence, dizziness and diarrhea. The company expects to present detailed results at upcoming medical meetings.