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
- Kathryn Mitchell Pierce, Ph.D.: 1955-2025Kathryn Mitchell Pierce, Ph.D., associate professor of educational studies, died Wednesday, Dec. 10, 2025. She was 70 years old. Pierce joined Saint Louis University in 2015 as an assistant professor in the School of Education. Initially a literacy specialist in the undergraduate program, she eventually taught and mentored across all levels at the School of Education. She became an associate professor in 2022.
- Saint Louis University Student Speaks About Leadership and Disability at Ignatian Family Teach-In for JusticeSaint Louis University senior Grace LoPiccolo shared her personal leadership journey at the 2025 Ignatian Family Teach-In for Justice. The event, held annually in Washington, D.C., is the nation’s largest Catholic social justice advocacy day.
- SLU Research Shows Surge in Alcohol-Related Liver Disease Driving ‘Deaths of Despair’Researchers at Saint Louis University School of Medicine say deaths from alcohol-related liver disease have surged in recent years, and the increase is hitting people without a college degree the hardest. While nearly every demographic group is seeing higher death rates—including those with college degrees—the gap between economically disadvantaged groups and more affluent ones is growing, according to new research.
- Saint Louis University Joins Multi-Disciplinary Research Team to Enhance Stress Resilience in SorghumSaint Louis University is part of a multi-disciplinary team, led by the Donald Danforth Plant Science Center, to deepen the understanding of sorghum, a versatile bioenergy crop, and its response to environmental challenges.The U.S. Department of Energy (DOE) Biological and Environmental Research (BER) program supports the three-year $2.5 million project for Genomics-Enabled Understanding and Advancing Knowledge on Plant Gene Function. Saint Louis University will receive $437,039 for its portion of the study.
- SLU Graduates Celebrated at Midyear CommencementSaint Louis University celebrated its Midyear Commencement on Saturday, Dec. 13, inside Chaifetz Arena. More than 1,900 guests watched as 600-plus SLU students walked across the stage and left as graduates.
- Why Do Raccoons Cross the Road? SLU, St. Louis Zoo Research Shows They Don'tA new study led by researchers from Saint Louis University, the Saint Louis Zoo, and partner organizations set out to understand how raccoons use space in one of the nation's largest urban parks.
