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Objective <p>This analysis aimed to evaluate the efficacy of brexpiprazole 2 or 3 mg/day for the treatment of agitation associated with dementia due to Alzheimer’s disease, on the basis of pooled clinical trial data.</p> Methods <p>Data were pooled from two similarly designed, phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trials of fixed-dose brexpiprazole in participants in care facilities or community-based settings who had agitation associated with dementia due to Alzheimer’s disease. Efficacy outcomes included Cohen-Mansfield Agitation Inventory (CMAI) total score (which measures the frequency of 29 different agitation symptoms), Clinical Global Impression-Severity of illness (CGI-S) score, CMAI factor scores (aggressive behaviors, physically nonaggressive behaviors, and verbally agitated behaviors), and response rates. A sensitivity analysis included a third trial with flexible dosing.</p> Results <p>In total, 621 participants were randomized (brexpiprazole, 368; placebo, 253), and completion rates were 320/368 (87.0%) and 225/253 (88.9%), respectively. Mean (SD) baseline CMAI total scores were: brexpiprazole 76.9 (17.2) points and placebo 75.5 (18.0) points. Over 12 weeks, CMAI total scores improved by least squares mean (SE) − 22.8 (0.8) points for brexpiprazole and − 18.3 (1.0) points for placebo, with a least squares mean difference between treatment arms of − 4.50 points (95% CI − 6.90 to − 2.10; <i>p</i> &lt; 0.001; Cohen’s <i>d</i> 0.30). CGI-S, CMAI factor, and response analyses also showed greater improvement with brexpiprazole versus placebo. The sensitivity analysis was supportive.</p> Conclusions <p>Brexpiprazole 2 or 3 mg/day reduced agitation symptoms compared with placebo over 12 weeks in this large, pooled sample of participants with dementia due to Alzheimer’s disease.</p> Study Registration <p>ClinicalTrials.gov identifiers: NCT01862640, NCT03548584, and NCT01922258.</p>

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Efficacy of Brexpiprazole in Participants with Agitation Associated with Dementia Due to Alzheimer’s Disease: Pooled Analysis of Randomized Controlled Trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月27日

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  • Jeffrey L. Cummings,
  • Sanjeda R. Chumki,
  • Denise Chang,
  • Zhen Zhang,
  • Malaak Brubaker,
  • Nanco Hefting,
  • Pedro Such,
  • David Wang,
  • George T. Grossberg

摘要

Objective

This analysis aimed to evaluate the efficacy of brexpiprazole 2 or 3 mg/day for the treatment of agitation associated with dementia due to Alzheimer’s disease, on the basis of pooled clinical trial data.

Methods

Data were pooled from two similarly designed, phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trials of fixed-dose brexpiprazole in participants in care facilities or community-based settings who had agitation associated with dementia due to Alzheimer’s disease. Efficacy outcomes included Cohen-Mansfield Agitation Inventory (CMAI) total score (which measures the frequency of 29 different agitation symptoms), Clinical Global Impression-Severity of illness (CGI-S) score, CMAI factor scores (aggressive behaviors, physically nonaggressive behaviors, and verbally agitated behaviors), and response rates. A sensitivity analysis included a third trial with flexible dosing.

Results

In total, 621 participants were randomized (brexpiprazole, 368; placebo, 253), and completion rates were 320/368 (87.0%) and 225/253 (88.9%), respectively. Mean (SD) baseline CMAI total scores were: brexpiprazole 76.9 (17.2) points and placebo 75.5 (18.0) points. Over 12 weeks, CMAI total scores improved by least squares mean (SE) − 22.8 (0.8) points for brexpiprazole and − 18.3 (1.0) points for placebo, with a least squares mean difference between treatment arms of − 4.50 points (95% CI − 6.90 to − 2.10; p < 0.001; Cohen’s d 0.30). CGI-S, CMAI factor, and response analyses also showed greater improvement with brexpiprazole versus placebo. The sensitivity analysis was supportive.

Conclusions

Brexpiprazole 2 or 3 mg/day reduced agitation symptoms compared with placebo over 12 weeks in this large, pooled sample of participants with dementia due to Alzheimer’s disease.

Study Registration

ClinicalTrials.gov identifiers: NCT01862640, NCT03548584, and NCT01922258.