Brexpiprazole for the Treatment of Agitation in Alzheimer's Disease Dementia: Clinical Uncertainties and the Path Forward.

Abstract

Brexpirazole was approved for the treatment of nonpsychotic agitation in Alzheimer's disease (AD) dementia by the United States Food and Drug Administration (FDA) in May 2023 after three phase 3 clinical trials found brexpiprazole 2 to 3 mg/day to be an effective and well-tolerated treatment for agitation in AD dementia, albeit with small effect sizes. It appeared to especially benefit dementia patients with severe agitation/aggression, but it took between 6 and 12 weeks across the three studies for the medication to separate from placebo. However, much remains unknown about its place in the psychopharmacological armamentarium for the treatment of AD dementia-related agitation, including the optimal duration of a brexpiprazole trial, bridging options during the time it takes for brexpiprazole to become effective, and whether it should be continued in the presence of or upon emergence of psychosis during treatment. This Research in Action article uses a case vignette to synthesize the findings of the brexpiprazole trials and apply them to clinical practice, highlight the current uncertainties associated with its use, and compare it with other psychopharmacological options for the treatment of agitation in AD dementia.