by A groundbreaking treatment for agitation associated with Alzheimer’s dementia has been developed by a researcher at Saint Louis University. The treatment, called REXULTI or brexpiprazole, has received approval from the Food and Drug Administration (FDA), making it the first and only FDA-approved treatment for this particular symptom.
The research, led by George T. Grossberg, M.D., the Director of Geriatric Psychiatry at Saint Louis University, was published in the prestigious medical journal JAMA Neurology. In the study, Grossberg and his colleagues shared the results of a national clinical trial, which demonstrated that brexpiprazole effectively reduced agitation in patients with Alzheimer’s disease, while also being well-tolerated with minimal side effects.
Agitation is a common symptom experienced by individuals with Alzheimer’s dementia, with studies showing that around half or more of those affected develop this symptom. Agitation can manifest in various ways, including restlessness and aggressive behavior such as screaming, destroying objects, or physical confrontation. These behavioral symptoms can be distressing not only for the patient but also for their families and caregivers.
Currently, antipsychotic drugs are often prescribed off-label to manage symptoms of aggression and agitation in Alzheimer’s patients. However, these medications have limited long-term use due to their adverse effects and potential health risks.
Grossberg expressed his encouragement at the findings of the study, stating that brexpiprazole is an effective and well-tolerated medication for treating the debilitating symptoms of agitation associated with Alzheimer’s disease. He further emphasized the difficulty of managing patients with Alzheimer’s-related agitation and highlighted the need for new treatment options.
The clinical trial for brexpiprazole was a multicenter Phase 3 study that involved 345 participants from 123 clinical trial sites across Europe and the United States. The trial spanned a period of 12 weeks and utilized a double-blind, placebo-controlled, fixed-dose, parallel-arm design.
Participants, aged between 55 and 90, were required to have a diagnosis of probable Alzheimer’s disease and clinically significant symptoms of agitation. They were randomly assigned to receive either brexpiprazole or a placebo. Caregiver compliance with the study procedures was also a prerequisite for participation.
Grossberg highlighted the significant challenges faced by healthcare providers and caregivers in managing patients with Alzheimer’s disease. The availability of new medications, such as brexpiprazole, will greatly benefit not only the patients but also those involved in their care.
The FDA approval of brexpiprazole marks a significant milestone in the treatment of Alzheimer’s-associated agitation. This breakthrough offers hope to millions of individuals living with this debilitating condition, as well as their families and caregivers. With further research and development, it is possible that new and improved treatments will continue to emerge, ultimately improving the quality of life for those affected by Alzheimer’s disease.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
