Brexpiprazole for Agitation
Trial question
What is the role of brexpiprazole in the treatment of agitation in patients with Alzheimer's disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 345
345 patients (195 female, 150 male).
Inclusion criteria: patients with Alzheimer's disease and agitation.
Key exclusion criteria: dementia or memory impairment due to a reason other than Alzheimer's disease; clinically significant neurological, psychiatric, or unstable medical condition.
Interventions
N=228 brexpiprazole (at an oral dose of 2 or 3 mg per day for 12 weeks).
N=117 placebo (matching placebo oral tablets for 12 weeks).
Primary outcome
Reduction in Cohen-Mansfield Agitation Inventory total score at week 12
22.6 points
17.3 points
22.6 points
17.0 points
11.3 points
5.7 points
0.0 points
Brexpiprazole
Placebo
Significant
increase ▲
Significantly greater reduction in Cohen-Mansfield Agitation Inventory total score at week 12 (22.6 points vs. 17.3 points; MD 5.32, 95% CI 1.87 to 8.77).
Secondary outcomes
Significantly greater reduction in Clinical Global Impression-Severity of illness score as related to agitation at week 12 (1.2 points vs. 0.9 points; MD 0.27, 95% CI 0.07 to 0.47).
Significant decrease in Clinical Global Impression-Improvement score at week 12 (2.7 points vs. 3 points; MD -0.33, 95% CI -0.57 to -0.09).
Significant increase in the percentage of patients achieving ≥ 20% improvement in Cohen-Mansfield Agitation Inventory at week 12 (68.4% vs. 47.4%; RR 1.41, 95% CI 1.15 to 1.72).
Safety outcomes
No significant differences in treatment-emergent adverse events, discontinuation of trial drug due to adverse events.
Conclusion
In patients with Alzheimer's disease and agitation, brexpiprazole was superior to placebo with respect to reduction in Cohen-Mansfield Agitation Inventory total score at week 12.
Reference
Daniel Lee, Mary Slomkowski, Nanco Hefting et al. Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia: A Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1307-1316.
Open reference URL