SLU Researcher Finds Help for Alzheimer's-Associated Agitation with New FDA-Approved Treatment
ST. LOUIS – A Saint Louis University researcher was instrumental in developing the first and only Food and Drug Administration (FDA) approved treatment for agitation associated with Alzheimer’s dementia.
In a paper published in JAMA Neurology, senior author and the inaugural Henry & Amelia Nasrallah Endowed Professor and Director of Geriatric Psychiatry at Saint Louis University George T. Grossberg, M.D., and colleagues shared the results of a national clinical trial. They discovered that REXULTI, also called brexpiprazole, significantly reduced agitation in patients with Alzheimer’s disease and was well tolerated with few side effects.
George Grossberg, M.D. Photo by Sarah Conroy.
Earlier this year, brexpiprazole became the first FDA-approved treatment of agitation-associated Alzheimer’s dementia.
Of the 6.7 million people 65 and older in the US with Alzheimer’s dementia, multiple studies show that about half or more develop agitation.
Agitation associated with Alzheimer’s dementia may include activities like restlessness or more aggressive behavior, like screaming, destroying objects or fighting. Frequent and severe behavioral symptoms can be extremely distressing to the person with Alzheimer’s disease, as well as their families and caregivers.
Antipsychotic drugs are commonly prescribed “off-label” to treat symptoms like aggression and agitation. While these antipsychotics seem to show a modest benefit in treating aggression in the short term, they have adverse effects and other health risks that limit their use over more extended periods.
“When patients with Alzheimer’s dementia develop agitation symptoms, they can become increasingly difficult to manage,” said Grossberg, who is also director of geriatric psychiatry at SLU. “I’m encouraged by the findings of this study which show that brexpiprazole is an effective and well-tolerated medication that can treat the often-debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.”
In the multicenter Phase 3 clinical trial, researchers evaluated the efficacy and safety of brexpiprazole, a medication used for the treatment of major depressive disorder and schizophrenia, for patients with agitation associated with Alzheimer’s.
The clinical trial was a 12-week, double-blind, placebo-controlled, fixed-dose, parallel-arm trial that enrolled 345 participants at 123 clinical trial sites in Europe and the United States.
Investigators enrolled participants between the ages of 55 to 90 with a diagnosis of probable Alzheimer’s disease and clinically significant symptoms of agitation who lived in a care facility or community-based setting.
Participants were randomly assigned to receive the study drug or a placebo. To participate in the clinical trial, participants had to be stable and have a caregiver who could comply with the study procedures.
“It can be extremely challenging to care for patients with Alzheimer’s disease,” said Grossberg. “Having new medications to help patients who are suffering will enormously benefit patients, healthcare providers, and those caring for their loved ones.”
The clinical trial was supported by Otsuka Pharmaceutical Development & Commercialization and H. Lundbeck.
For more information about the trial, visit ClinicalTrials.gov. The study’s Clinical Trials Identifier is NCT03548584.
Latest Newslink
- SLU Researchers Identify Sex-Based Differences in Immune Responses Against TumorsResearchers at Saint Louis University School of Medicine investigated differences in T-cell responses between male and female patients with lung cancer that may help direct future treatments. T-cell responses are part of the adaptive immune system, which is part of the body's "smart system" that monitors for threats and fights them with customized defenses.
- Department of Energy Awards Saint Louis University Nearly $1 Million to Create a Climate Resilience CenterSaint Louis University has received a $964,848 grant from the U.S. Department of Energy (DOE) to create a Climate Resilience Center at SLU. The project is one of 10 centers funded by the DOE in states nationwide.
- SLU’s Farzana Hoque Named a YWCA Metro St. Louis 2024 Leader of DistinctionNominees are put forth by their peers and selected by an independent panel based on their professional achievements and contributions to the community. Farzana Hoque, M.D., associate professor of internal medicine and acting internship co-director, will be honored at the 44th Annual YWCA Leader Lunch on Friday, Dec. 13.
- SLU’s Alec Pollard Receives International OCD Foundation Outstanding Career Achievement AwardAlec Pollard, Ph.D., professor emeritus of family and community medicine, recently received the International OCD Foundation (IOCDF)’s 2024 Outstanding Career Achievement Award. The IOCDF Awards recognize exceptional individuals and professionals for their dedicated efforts in advancing awareness, advocacy, and understanding of obsessive-compulsive disorder.
- SLU Pregnancy Loss Researcher Denise Côté-Arsenault Receives Fulbright Specialist Program AwardDenise Côté-Arsenault, Ph.D., the Hemak Endowed professor of maternal child nursing, has received a Fulbright Specialist Program award, the U.S. Department of State and the Fulbright Foreign Scholarship Board recently announced.
- Pioneering Breast Surgeon Gives $7.3 Million to Saint Louis University to Support Catholic Education, Underserved CommunitiesSaint Louis University announced a historic donation to the University’s School of Education from physician and alumna Virginia (Ginny) Herrmann, M.D. The $7.3 million gift will establish the Herrmann Center for Innovative Catholic Education, as well as support education programs at every educational level and underserved students throughout the St. Louis region.