Clinical Question

Does brexpiprazole (Rexulti) decrease agitation in adults with Alzheimer disease and agitated behaviors?

Bottom Line

In the study of patients with Alzheimer disease and agitated behaviors, brexpiprazole modestly reduced agitation scores and was well tolerated. (Level of Evidence = 1b)

Synopsis

Researchers randomly assigned adults with Alzheimer disease and agitated behaviors to receive brexpiprazole (n = 226; 2 or 3 mg daily) or placebo (n = 116) for 12 weeks. The researchers evaluated the patients' scores on various validated measures of agitation and global assessments every 2 weeks. Approximately 87% of the patients (mean age was 74 years; 56.5% were female) completed the study. At the end of the study, the brexpiprazole-treated patients had a greater reduction in agitation scores than the placebo-treated patients (effect size was 0.35, which corresponds to a small to medium effect size) and a similar change in global assessment scores (effect size was 0.31, which also corresponds to a small to medium effect size). Medication discontinuation due to adverse effects was similar in the two groups (4.3% of the participants treated with placebo vs. 5.3% of those treated with brexpiprazole).