Efficacy of Brexpiprazole in Patients With Agitation Associated With Alzheimer’s Dementia Analyzed by Presence or Absence of Psychosis: a Pooled Analysis

This work was sponsored by Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark) Agitation is a prevalent manifestation of Alzheimer’s dementia, which can co-present with psychosis symptoms. Presence of either symptom is associated with accelerated disease progression. This analysis explored the efficacy of brexpiprazole in patients with agitation associated with Alzheimer’s dementia, based on presence or absence of baseline psychosis. This is a post hoc analysis of two Phase 3, placebo-controlled, fixed-dose trials of brexpiprazole in patients with agitation associated with Alzheimer’s dementia (NCT01862640 and NCT03548584). In each study, the primary endpoint was the change in Cohen-Mansfield Agitation Inventory (CMAI) Total score from baseline to Week 12. Presence of baseline psychosis was defined as a Neuropsychiatric Inventory delusion item and/or hallucination item score ≥4. Data were pooled from the two studies (brexpiprazole 2 or 3 mg/day compared with placebo). Mean CMAI Total scores at baseline were 82.4 (brexpiprazole) and 84.1 (placebo) in patients with baseline psychosis (n=142), and 75.1 and 73.0, respectively, in patients without baseline psychosis (n=465). The mean change in CMAI Total score at Week 12 was -25.11 (brexpiprazole) versus -19.09 (placebo) in the subgroup with baseline psychosis (p=0.043), and -20.48 versus -16.31, respectively, in the subgroup without baseline psychosis (p=0.0021). In patients with agitation associated with Alzheimer’s dementia, with or without baseline psychosis, brexpiprazole was associated with improvement in symptoms of agitation versus placebo.