Las Vegas medical school study shows 35% increase in clinical trials since 2016.

Axsome Therapeutics’ Auvelity expanded its label to include treating agitation in Alzheimer’s disease patients. It’s just the second FDA-approved drug for this indication, and Axsome’s pill has a safety advantage.

Four years after gaining FDA approval for Auvelity to treat major depressive disorder (MDD), Axsome Therapeutics has tacked on a second nod in the United States for the first-in-class medicine to treat agitation associated with dementia caused by Alzheimer’s disease.

The agency’s decision marks the first approval of a drug with this specific mechanism of action for one of the most burdensome and clinically challenging symptoms of the disease.

Up to 76% of patients with Alzheimer’s disease experience agitation, including pacing, restlessness and verbal or physical aggression.

A new family of drugs works to rid Alzheimer’s Disease patients’ brains of the proteins believed to be behind the memory-robbing illness.

The new report, published in the peer-reviewed academic journal Alzheimer’s Research & Therapy, involved medical experts and researchers in dementia from the National Institutes of Health in Baltimore, the Icahn School of Medicine at Mount Sinai in New York, the University of Nevada in Las Vegas, and the Medical University of South Carolina in Charleston, S.C.

GLP-1s have been a breakthrough for obesity and diabetes. A 2022 study examined data from trials of GLP-1s in nearly 16,000 patients with diabetes, and showed that the drugs were associated with a 53% reduction in dementia risk.

Details from two large trials of Novo Nordisk's NOVOb.CO GLP-1 drug semaglutide showed it provided no cognitive benefit for people with early Alzheimer's disease, researchers said at a medical meeting on Wednesday, dashing remaining hopes that the widely used medication could help such patients.

Doctor Jeffrey Cummings is world-renowned in the field of Alzheimer’s research and he leads UNLV’s Center for Transformative Neuroscience. He and six other scientists published research Wednesday that looked at the potential existing drugs have for the research and treatment of Alzheimer’s, for example, drugs like rasagiline for Parkinson’s or bexarotene for cancer. It’s called repurposing.

On Nov. 7, 2024, the U.S. Food and Drug Administration (FDA) granted icometrix clearance for icobrain aria, the first AI software approved for detecting, measuring and grading amyloid-related imaging abnormalities (ARIA), a potentially harmful side effect of new amyloid-targeting therapies. A large study, needed for FDA clearance, demonstrated that the use of icobrain aria significantly increases the accuracy of ARIA assessments by radiologists and hence allows for safer use of new amyloid-beta targeting therapies for Alzheimer’s disease patients.

Alzheimer’s patients and their loved ones have a renewed sense of hope now that the U.S. Food & Drug Administration approved the first Alzheimer’s drug in nearly two decades.