A phase 3 study supported the FDA approval of brexpiprazole for Alzheimer’s disease (AD) agitation, showing notable improvement over 12 weeks with 2- or 3-mg doses. The international trial involved 345 patients with AD who were mostly White with moderate cognitive impairment, where brexpiprazole effectively improved primary and secondary endpoints compared with placebo. Some adverse events and slight weight gain were observed in patients on brexpiprazole.
Reference: Meglio, M. Alzheimer Agitation Therapy Brexpiprazole Proves Efficacy in Full Phase 3 Dataset. Neurology Live. Updated January 11, 2024. Accessed January 17, 2024. https://www.neurologylive.com/view/alzheimer-agitation-therapy-brexpiprazole-efficacy-full-phase-3-dataset