Brexpiprazole treatment for agitation in Alzheimer's dementia: A randomized study

Abstract INTRODUCTION We evaluated the efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer's dementia (AAD) in Japanese patients. METHODS This was a phase 2/3 multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. Patients with AAD were randomized to receive brexpiprazole 1 mg/day or 2 mg/day, or placebo (3:4:4) for 10 weeks. RESULTS For the primary endpoint (change in Cohen‐Mansfield Agitation Inventory CMAI total score from baseline to Week 10), both brexpiprazole 1 mg and 2 mg groups demonstrated statistically significant improvement versus placebo (2 mg: least squares LS mean difference –7.2 95% confidence interval (CI): –10.0 to –4.3, p ‐value < 0.0001, 1 mg: LS mean difference –3.7 95% CI: –6.8 to –0.7, p ‐value = 0.0175). The incidences of treatment‐emergent adverse events reported in the brexpiprazole 1 mg, 2 mg, and placebo groups were 76.8%, 84.6%, and 73.8%, respectively. DISCUSSION Brexpiprazole 1 mg/day and 2 mg/day for 10 weeks was efficacious and well tolerated. Highlights Brexpiprazole treatment for 10 weeks improved agitation in Alzheimer's dementia. The efficacy of brexpiprazole 1 mg/day has been confirmed for the first time. The incidence of adverse events was higher compared to the previous studies. Both brexpiprazole 1 mg/day and 2 mg/day were generally well tolerated.