Abstract
INTRODUCTION: We evaluated the impacts of brexpiprazole treatment on patient neuropsychiatric symptoms and caregiver distress in Japanese patients with agitation in Alzheimer's dementia (AAD). METHODS: In a phase 2/3 multicenter, double-blind study, patients were randomized to receive brexpiprazole 1 or 2 mg/day, or placebo (3:4:4) for 10 weeks. The Neuropsychiatric Inventory (NPI) was used for evaluation. The areas of patient symptoms and caregiver distress were defined as NPI and NPI-Distress, respectively. RESULTS: At Week 10, the differences of brexpiprazole 1 and 2 mg versus placebo for NPI total score were -1.2 (p = 0.5891) and -8.4 (p < 0.0001), and those for NPI-Distress total score were -1.1 (p = 0.2292) and -3.9 (p < 0.0001), respectively. In brexpiprazole 2 mg versus placebo, NPI and NPI-Distress agitation/aggression score showed ≥ 2 and ≥ 1 point improvement, respectively. DISCUSSION: Brexpiprazole is suggested to improve patient symptoms and to reduce caregiver distress in the treatment of AAD in Japanese patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03620981 HIGHLIGHTS: Brexpiprazole improved symptoms of patients with agitation in Alzheimer's dementia. The improvements included not only agitation, but also various behavioral and psychological symptoms of dementia scores. The improvements of patient symptoms led to the reduction of caregiver distress. Our study suggests that brexpiprazole is beneficial for both patients and caregivers.