Treatment with brexpiprazole led to a significant improvement in agitation for people with Alzheimer's dementia, according to results from a clinical trial recently published in JAMA Neurology. The study was a randomised, multicenter and double-blind Phase III clinical trial evaluating the efficacy, safety and tolerability of brexpiprazole in people with agitation in Alzheimer's dementia. In totral, 345 participants received either placebo or brexpiprazole (2 or 3mg/day) daily over 12 weeks.
The study was conducted at 123 clinical trial sites in Europe and the United States. Participants included people with agitation in Alzheimer's dementia in a care facility or community-based setting. The primary en point was change in the Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline to week 12. The secondary endpoint was change in the Clinical Global Impression Severity of Illness (CGI-S) and Improvement (CGI-I) scales and the Neuropsychiatric Inventory–Nursing Home (NPI-NH) Agitation/Aggression domain score. Safety was assessed by standard measures, including treatment-emergent adverse events.
According to results, completion rates were 86.8% for participants taking brexpiprazole and 88.9% for those receiving placebo. Researchers reported statistically significant improvement in the brexpiprazole group compared with those given placebo in CMAI total score and CGI-CS score as related to agitation. In addition, brexpiprazole was generally well tolerated over 12 weeks. The findings support the US Food and Drug Administration approval of brexpiprazole for the use in the treatment of agitation associated with dementia due to Alzheimer’s disease. https://jamanetwork.com/journals/jamaneurology/fullarticle/2811629
