Nakamura Yu, Adachi Jun, Hirota Naoki, Iba Katsuhiro, Shimizu Koichi, Nakai Masami, Mori Naoki, Takahashi Kaneyoshi
Faculty of Medicine/Graduate School of Medicine, Kagawa University, Kagawa, Japan.
Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
J Alzheimers Dis Rep. 2025 Apr 16;9:25424823251334054. doi: 10.1177/25424823251334054. eCollection 2025 Jan-Dec.
The long-term safety and efficacy of brexpiprazole in Asian patients with agitation associated with dementia due to Alzheimer's disease are unknown.
To evaluate the safety of 14-week treatment with brexpiprazole 1 or 2 mg/day in Japanese patients who completed the 10-week double-blind treatment period in a parent phase 2/3 study, and to explore the efficacy of brexpiprazole.
This was a phase 3 multicenter, open-label study (ClinicalTrials.gov Identifier NCT03724942, registered on 28 October 2018). Patients who had completed 10-week treatment of placebo, 1 or 2 mg/day of brexpiprazole in a parent study were rolled over into this extended study. The primary endpoint was the frequency of adverse events.
Of 183 patients with informed consent, 164 were treated with brexpiprazole 1 or 2 mg/day for 14 weeks (prior brexpiprazole subgroup: 102 patients, prior placebo subgroup: 62 patients), and the overall study completion rate was 71.3%. The overall incidence of treatment-emergent adverse events was 90.2% (in each subgroup, 90.2% and 90.3%, respectively). Most treatment-emergent adverse events were mild or moderate in severity, and no new safety signals were observed. Regarding the Cohen-Mansfield Agitation Inventory total score at Week 14 (last observation carried forward), the mean change from baseline (standard deviation) was -4.0 (9.8).
The extended 14-week treatment with brexpiprazole 1 or 2 mg/day after 10-week treatment was generally well tolerated in Japanese patients with agitation associated with dementia due to Alzheimer's disease, and the efficacy was maintained.
布雷哌唑用于亚洲阿尔茨海默病所致痴呆伴激越患者的长期安全性和有效性尚不清楚。
在一项2/3期母研究中完成10周双盲治疗期的日本患者中，评估每天服用1毫克或2毫克布雷哌唑进行14周治疗的安全性，并探讨布雷哌唑的疗效。
这是一项3期多中心、开放标签研究（ClinicalTrials.gov标识符NCT03724942，于2018年10月28日注册）。在母研究中完成10周安慰剂、每天1毫克或2毫克布雷哌唑治疗的患者转入该扩展研究。主要终点是不良事件的发生频率。
在183例获得知情同意的患者中，164例接受了每天1毫克或2毫克布雷哌唑治疗14周（先前接受布雷哌唑治疗亚组：102例患者，先前接受安慰剂治疗亚组：62例患者），总体研究完成率为71.3%。治疗中出现的不良事件总发生率为90.2%（各亚组分别为90.2%和90.3%）。大多数治疗中出现的不良事件为轻度或中度，未观察到新的安全信号。关于第14周（末次观察结转）的科恩-曼斯菲尔德激越量表总分，相对于基线的平均变化（标准差）为-4.0（9.8）。
在10周治疗后，每天服用1毫克或2毫克布雷哌唑进行为期14周的延长治疗，对于日本阿尔茨海默病所致痴呆伴激越患者总体耐受性良好，且疗效得以维持。
