Brexpiprazole With Antidepressants for Agitation in Alzheimer’s Dementia: Post Hoc Analysis

OBJECTIVE: To analyze the efficacy and safety of brexpiprazole versus placebo on agitation symptoms in participants with Alzheimer's dementia, with and without concomitant antidepressants. METHODS: Data were pooled from two Phase 3, 12-week, randomized, double-blind, placebo-controlled trials of brexpiprazole (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Post hoc, participants were stratified by antidepressant use. Efficacy was assessed using the Cohen-Mansfield Agitation Inventory (CMAI) and safety using treatment-emergent adverse events (TEAEs). RESULTS: = -2.2, p = 0.025; Cohen's d = 0.20). Falls were the only TEAE reported for ≥5% of participants with concomitant antidepressant (brexpiprazole, 6.5%; placebo, 5.7%). CONCLUSION: In this exploratory post hoc analysis, brexpiprazole improved agitation symptoms and was generally well tolerated in participants with Alzheimer's dementia with and without concomitant antidepressants.