Positive Data for First and Only Treatment Approved for Agitation in Alzheimer Dementia

Recently released positive phase 3 trial data of brexpiprazole (Rexulti)—the first and only treatment approved to treat agitation associated with dementia due to Alzheimer disease—showed it reduced agitation in Alzheimer dementia significantly in 3 agitation symptoms categories: aggressive behaviors, physically nonaggressive behaviors, and verbally agitated behaviors.

“Treatment of agitation is essential to increase the comfort, quality of life, and safety of patients with Alzheimer dementia; to ease the burden on their caregivers; and to allow patients to live at home longer,” wrote the authors.¹

In this randomized clinical trial, 345 participants received either oral brexpiprazole 2 mg/d or 3 mg/d or placebo. Participants receiving brexpiprazole (n = 225) demonstrated a statistically significant reduction in agitation compared with placebo (n = 116) over 12 weeks, measured using the Cohen-Mansfield Agitation Inventory (CMAI) total score (p=0.003). JAMA Neurology published the complete results.

“The study is timely, since the treatment of agitation in this patient group remains a high treatment priority, and the options for pharmacological interventions are limited,” wrote Clive Ballard, MD, PhD in an accompanying editorial.²

Adverse effects were reported by 40.7% of the brexpiprazole group and 31.0% of the placebo group, with headache as the only adverse effect with an incidence of greater than 5% in the brexpiprazole group.

References

1. Lee D, Slomkowski M, Hefting N, et al. Brexpiprazole for the treatment of agitation in Alzheimer dementia: a randomized clinical trial. JAMA Neurol. November 6, 2023.

2. Ballard C. Brexpiprazole for the treatment of agitation and aggression in Alzheimer disease. JAMA Neurol. November 6, 2023.