Brexpiprazole treatment for agitation in Alzheimer's dementia: A randomized study.

Autor: Nakamura Y; Faculty of Medicine/Graduate School of Medicine, Kagawa University, Kita-gun, Kagawa, Japan., Adachi J; Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Minato-ku, Tokyo, Japan., Hirota N; Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Minato-ku, Tokyo, Japan., Iba K; Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Chuo-ku, Osaka, Japan., Shimizu K; Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Minato-ku, Tokyo, Japan., Nakai M; Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Chuo-ku, Osaka, Japan., Takahashi K; Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Minato-ku, Tokyo, Japan., Mori N; Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Minato-ku, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Alzheimer's & dementia : the journal of the Alzheimer's Association [Alzheimers Dement] 2024 Oct 06. Date of Electronic Publication: 2024 Oct 06.
DOI: 10.1002/alz.14282
Abstrakt: Introduction: We evaluated the efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer's dementia (AAD) in Japanese patients.
Methods: This was a phase 2/3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients with AAD were randomized to receive brexpiprazole 1 mg/day or 2 mg/day, or placebo (3:4:4) for 10 weeks.
Results: For the primary endpoint (change in Cohen-Mansfield Agitation Inventory [CMAI] total score from baseline to Week 10), both brexpiprazole 1 mg and 2 mg groups demonstrated statistically significant improvement versus placebo (2 mg: least squares [LS] mean difference -7.2 [95% confidence interval (CI): -10.0 to -4.3], p-value < 0.0001, 1 mg: LS mean difference -3.7 [95% CI: -6.8 to -0.7], p-value = 0.0175). The incidences of treatment-emergent adverse events reported in the brexpiprazole 1 mg, 2 mg, and placebo groups were 76.8%, 84.6%, and 73.8%, respectively.
Discussion: Brexpiprazole 1 mg/day and 2 mg/day for 10 weeks was efficacious and well tolerated.
Highlights: Brexpiprazole treatment for 10 weeks improved agitation in Alzheimer's dementia. The efficacy of brexpiprazole 1 mg/day has been confirmed for the first time. The incidence of adverse events was higher compared to the previous studies. Both brexpiprazole 1 mg/day and 2 mg/day were generally well tolerated.
(© 2024 The Author(s). Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)
Databáze: MEDLINE
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