On 1 December, Otsuka Pharmaceutical and Lundbeck presented findings from three Phase III studies showing that brexpiprazole significantly improved symptoms of agitation in people with Alzheimer’s dementia at the 2022 Clinical Trials for Alzheimer’s Disease (CTAD) conference. Behavioral symptoms, such as agitation, are core features in people with Alzheimer's disease and related dementia. Brexpiprazole is an antipsychotic drug, which is already licenced for schizophrenia. The aim of these tree 12-week, randomised, double-blind and placebo-controlled studies were to evaluate the safety and efficacy of brexpiprazole in people with agitation in Alzheimer’s dementia. The primary endpoint across the studies was improvement from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score while the key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression-Severity (CGI-S) score related to agitation.
Study 1 investigated two fixed doses of brexpiprazole (1 mg/day and 2 mg/day), study 2 investigated flexibly dosed brexpiprazole (0.5–2 mg/day) whereas study 3 investigated fixed doses of brexpiprazole (2 mg/day and 3 mg/day). Data showed that brexpiprazole (2 and 3 mg/day) significantly improved symptoms of agitation in people with Alzheimer’s dementia compared to placebo from baseline to week 12 in the CMAI total and CGI-S score as related to agitation. Brexpiprazole showed a favorable safety and tolerability profile in all three studies. The most common adverse effects experienced were insomnia (3.7% in the brexpiprazole group versus 2.8% in the control group), somnolence (3.4% versus 1.8%), nasopharyngitis (2.7% versus 2.6%), and urinary tract infection (2.6% versus 1.5%).
