Rexulti improves agitation in Alzheimer's disease

Findings from two phase 3 clinical trials indicated efficacy, safety and tolerability of Rexulti for agitation in individuals with Alzheimer’s disease.

Rexulti (brexpiprazole, Otsuka) is currently approved for treatment of schizophrenia and as adjunctive treatment for major depression.

To assess efficacy, safety and tolerability of brexpiprazole for agitation in Alzheimer’s disease, researchers conducted two randomized, double-blind, placebo-controlled studies among approximately 700 individuals. Study participants were aged 51 to 90 years and diagnosed with probable Alzheimer’s disease and symptoms of agitation. The cohort included both outpatients and individuals living in institutional care settings. One trial assessed fixed doses of 1 mg or 2 mg of brexpiprazole or placebo per day, while the other studied flexible-dose ranges of 0.5 mg, 1 mg, or 2 mg of brexpiprazole or placebo per day. Study duration was 12 weeks.

In the first study, participants who received 2 mg of brexpiprazole exhibited greater improvements in Cohen-Mansfield Agitation Inventory (CMAI) total scores, compared with the placebo group (P < .05).

Improvements in CMAI scores were greater than improvements in Clinical Global Impression-Severity of Illness (CGI-S) scores among participants who received 2 mg of brexpiprazole in the first study.

In the second study, improvements in CMAI (P > .05) were less robust than improvements in CGI-S (P < .05), according to researchers.

The most common adverse events among participants who received brexpiprazole were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%) and somnolence (3.3% vs. 2.2%), compared with the placebo group.

Data in both studies varied between countries, potentially due to different care standards, according to researchers. Data from Russian study sites showed particularly poor separation between brexpiprazole and placebo.