Efficacy of Brexpiprazole on Neuropsychiatric Symptoms and Impact on Caregivers: Pooled Neuropsychiatric Inventory (NPI) Analysis in Patients With Agitation Associated With Dementia due to Alzheimer's Disease.

PurposeAgitation is a neuropsychiatric symptom commonly observed in Alzheimer's dementia, which causes substantial burden for patients and caregivers. In this exploratory analysis, Neuropsychiatric Inventory (NPI) data were pooled from two randomized, double-blind, fixed-dose, placebo-controlled trials of brexpiprazole in agitation associated with dementia due to Alzheimer's disease. The analysis explored the efficacy of brexpiprazole on agitation and other neuropsychiatric symptoms, including their impact on caregivers.Major FindingsBrexpiprazole 2 or 3 mg/day (N = 368) showed greater improvement vs placebo (N = 253) from baseline in NPI agitation/aggression domain score (Week 6 onwards), and in the associated occupational disruptiveness/caregiver distress score (Week 4 onwards). Improvements with brexpiprazole vs placebo also occurred on other NPI and occupational disruptiveness/caregiver distress scores, including irritability/lability, aberrant motor behavior, and anxiety.ConclusionsOver 12 weeks, brexpiprazole was associated with greater improvements vs placebo in agitation/aggression and other neuropsychiatric symptoms, and in associated caregiver disruption/distress. ClinicalTrials.gov identifiers: NCT01862640; NCT03548584.