Clinical Trial Supports Use of Brexpiprazole for Alzheimer ' s Agitation, Study Suggests

The Food and Drug Administration ’sdecision to approve brexpiprazole (Rexulti) for the treatment of agitation related to Alzheimer ’s disease in May was met with a mixed response. While some viewed the drug approval as apositive step for treating a common behavioral symptom of dementia,others questioned whether the benefits of the medication were worth the risk. Today,JAMA Neurologypublished the results of a key phase 3 clinical trial used in the FDA ’s decision.The trial of adults aged 55 to 90 with a diagnosis of probable Alzheimer ’s disease who were experiencing agitation found that those who took brexpiprazole daily experienced a modestly greater drop in agitation behaviors over a 12-week period than those who took placebo. The study was funded by Otsuka Pharmaceutical and H. Lundbeck, co-developers of the drug.“Treatment of agitation is essential to increase the comfort, quality of life, and safety of patients with Alzheimer dementia; to ease the burden on their caregivers; and to allow patients to live at home longer,” wrote Daniel Lee, M.D., of Otsuka and colleagues.Lee and colleagues enrolled 345 adults with Alzheimer ’s from clinical sites across Europe and the United States. The participants all had agitation symptoms that necessitated medication for at least two weeks prior to baseline screening. The participants also had to be living in a care facility or community-based setting and have a caregiver with en ough contact to be able to describe the pa...
Source: Psychiatr News - Category: Psychiatry Tags: agitation Alzheimer ' s disease brexpiprazole CMAI FDA Food and Drug Administration JAMA Neurology Lundbeck Otsuka side effects Source Type: research