Phase 2/3 Trial of Treatment for Agitation in Alzheimer’s to Conclude Early

Phase 2/3 Trial of Treatment for Agitation in Alzheimer’s to Conclude Early
Axsome Therapeutics is planning to complete its ADVANCE-1 clinical trial, evaluating AXS-05 as a treatment for agitation in Alzheimer’s disease, a few months earlier to ensure the safety of study participants during the COVID-19 pandemic. Top-line results from this Phase 2/3 trial, which opened in 2017, are now expected in April or May, rather than later this year as anticipated. AXS-05 is an investigational oral medication to treat agitation — an umbrella term that refers to feelings of restlessness, emotional distress, aggression, irritability, and a loss of social awareness — in Alzheimer's. Its two main active components, dextromethorphan and bupropion, modulate the activity of neurotransmitters, chemicals used to send signals in the brain, in ways that may ease agitation. This symptom is present is as many as half of all patients, but lacks a targeted treatment. The ADVANCE-1 clinical trial (NCT03226522) is evaluating AXS-05's effectiveness and safety in Alzheimer's patients 65 and older. It initially intended to enroll 435 participants, divided evenly into three arms: an AXS-05, a placebo, or bupropion-only group. Following a pre-planned interim analysis in late 2018, however, enrollment in the bupropion arm ceased; those subsequently entering the study were assigned randomly to either AXS-05 or placebo. Participants are treated for five weeks, and agitation severity is assessed using the Cohen-Mansfield Agitation Inventory (CMAI), the study's primary effectiveness measure. This a 29-item scale systematically assesses the frequency with which patients manifest physically aggressive, physically non-aggressive, and verbally agitated behaviors. Both the AXS-05 and placebo trial groups are fully enrolled, and more than 90% of patients i
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