P96: Efficacy of Brexpiprazole for the Treatment of Agitation in Alzheimer’s Dementia: Post Hoc Line Item Analysis of the Cohen-Mansfield Agitation Inventory

Abstract

Objective:Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia. The Cohen-Mansfield Agitation Inventory (CMAI) assesses the frequency of 29 agitation behaviors in elderly persons. The frequency of each behavior is rated from 1–7 (1=never, 2=less than once a week, 3=once or twice a week, 4=several times a week, 5=once or twice a day, 6=several times a day, 7=several times an hour), typically reported as a single total score. This post hoc analysis explored the efficacy of brexpiprazole on the frequency of individual agitation behaviors.Methods:Post hoc analyses were conducted for two 12-week, randomized, double- blind, placebo-controlled, parallel-arm, fixed-dose trials of brexpiprazole in patients with agitation in Alzheimer’s dementia (NCT01862640, NCT03548584). Data are reported using descriptive statistics for brexpiprazole (2 or 3 mg/day) and placebo, for patients who completed 12 weeks of treatment.Results:In the first fixed-dose trial (brexpiprazole 2 mg/day, n=120; placebo, n=118), baseline behavior frequency was similar between groups (range 1.12 to 4.92). At baseline, the most frequently observed behavior was “general restlessness” (brexpiprazole, 4.92; placebo, 4.82; approximately “once or twice a day”), and the least frequently observed behaviors were “biting” (brexpiprazole, 1.12) and “making physical sexual advances” (placebo, 1.14). At Week 12, the average reduction in mean frequency was -0.73 (brexpiprazole) and -0.60 (placebo), with a greater numerical reduction for 21/29 behaviors with brexpiprazole versus placebo. In the second fixed-dose trial (brexpiprazole 2 or 3 mg/day, n=192; placebo, n=103), baseline behavior frequency was similar between groups (range 1.12 to 5.22), and higher than in the first trial due to study inclusion criteria. At baseline, the most frequently observed behavior was “general restlessness” (brexpiprazole, 5.22; placebo, 5.09; approximately “once or twice a day”), and the least frequently observed behaviors were “making physical sexual advances” (brexpiprazole, 1.13) and “intentional falling” (placebo, 1.12). At Week 12, the average reduction in mean frequency was -0.78 (brexpiprazole) and -0.54 (placebo), with a greater numerical reduction for 26/29 behaviors with brexpiprazole versus placebo.Conclusion:In this post hoc analysis, brexpiprazole was associated with numerically greater reduction in the frequency of most individual agitation behaviors versus placebo.