Grossberg GT, Kohegyi E, Mergel V, et al. - Researchers examined the efficacy, safety, and tolerability of brexpiprazole in patients with agitation in Alzheimer dementia (AAD) via performing two 12-week, randomized, double-blind, placebo-controlled, parallel-arm studies. Study 1 was conducted at 81 sites in 7 countries while Study 2 was conducted at 62 sites in 9 countries. Patients with AAD (Study 1: 433 randomized; Study 2: 270 randomized) in study 1 were given fixed doses of brexpiprazole—2 mg/day or 1 mg/day—or placebo (1:1:1) for 12 weeks; in study 2 they were provided flexible doses of brexpiprazole at 0.5–2 mg/day or placebo (1:1) for 12 weeks. In Study 1, findings demonstrated the superiority of brexpiprazole 2 mg/day (fixed dose) vs placebo in terms of improvement of agitated behaviors (measured using the Cohen-Mansfield Agitation Inventory), with good tolerability. In Study 2, findings demonstrated the numerical superiority (a non-statistically significant difference) of brexpiprazole 0.5–2 mg/day vs placebo; nominal superiority was achieved in the subgroup titrated to brexpiprazole 2 mg/day vs similarly titrated placebo patients. These studies provided evidence supporting the potential of brexpiprazole 2 mg/day as an efficacious, safe, and well-tolerated treatment for AAD.