The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2026
Brexpiprazole With Antidepressants for Agitation in Alzheimer's Dementia: Post Hoc Analysis.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Montano C Brendan, Chumki Sanjeda R, Wang David, Palma Anton M, Zhang Zhen, Porsteinsson Anton P
Аннотация
OBJECTIVE: To analyze the efficacy and safety of brexpiprazole versus placebo on agitation symptoms in participants with Alzheimer's dementia, with and without concomitant antidepressants.
METHODS: Data were pooled from two Phase 3, 12-week, randomized, double-blind, placebo-controlled trials of brexpiprazole (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Post hoc, participants were stratified by antidepressant use. Efficacy was assessed using the Cohen-Mansfield Agitation Inventory (CMAI) and safety using treatment-emergent adverse events (TEAEs).
RESULTS: Brexpiprazole 2 or 3 mg/day improved CMAI Total score versus placebo in participants with concomitant antidepressant (n = 97; least squares mean difference at Week 12, -12.1 [95% confidence interval, -19.1 to -5.05]; t(77) = -3.4, p = 0.001; Cohen's d = 0.72) and without concomitant antidepressant (n = 513; -2.93 [-5.49 to -0.37]; t(487) = -2.2, p = 0.025; Cohen's d = 0.20). Falls were the only TEAE reported for ≥5% of participants with concomitant antidepressant (brexpiprazole, 6.5%; placebo, 5.7%).
CONCLUSION: In this exploratory post hoc analysis, brexpiprazole improved agitation symptoms and was generally well tolerated in participants with Alzheimer's dementia with and without concomitant antidepressants.
METHODS: Data were pooled from two Phase 3, 12-week, randomized, double-blind, placebo-controlled trials of brexpiprazole (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Post hoc, participants were stratified by antidepressant use. Efficacy was assessed using the Cohen-Mansfield Agitation Inventory (CMAI) and safety using treatment-emergent adverse events (TEAEs).
RESULTS: Brexpiprazole 2 or 3 mg/day improved CMAI Total score versus placebo in participants with concomitant antidepressant (n = 97; least squares mean difference at Week 12, -12.1 [95% confidence interval, -19.1 to -5.05]; t(77) = -3.4, p = 0.001; Cohen's d = 0.72) and without concomitant antidepressant (n = 513; -2.93 [-5.49 to -0.37]; t(487) = -2.2, p = 0.025; Cohen's d = 0.20). Falls were the only TEAE reported for ≥5% of participants with concomitant antidepressant (brexpiprazole, 6.5%; placebo, 5.7%).
CONCLUSION: In this exploratory post hoc analysis, brexpiprazole improved agitation symptoms and was generally well tolerated in participants with Alzheimer's dementia with and without concomitant antidepressants.