Axsome’s expectation that AXS-05 can win market share from Rexulti is partly built on the belief that the drug candidate has a differentiated safety profile. Rexulti has a boxed warning because of an increased risk of death. There were no deaths in the AXS-05 trials. Jeffrey Cummings, a research professor at the University of Nevada, Las Vegas, discussed what may happen if AXS-05 avoids a boxed warning.

Axsome Therapeutics said on Monday it would seek marketing approval next year for its oral drug to treat agitation in patients with Alzheimer’s disease, after it succeeded in three out of four late-stage studies.

Today, Axsome will host a conference call and webcast to discuss these topline results. Dr. Jeffrey Cummings, Vice Chair of Research at UNLV Department of Brain Health, will join the call and be available for questions.

Cleveland Clinic Genome Center researchers have unraveled how microglia, which perform key neuroprotective activities, also can transform and drive harmful processes such as inflammation in Alzheimer’s disease.

The Food and Drug Administration (FDA) has granted 510(k) clearance to Icobrain Aria (Icometrix, Boston, MA), a software that provides computer-assisted, automatic detection and severity grading for amyloid-related imaging abnormalities (ARIA). Icobrain Aria generates a quantitative summary report for MRI images, including severity rating scores based on the measurement and summarization of ARIA cerebral edema (ARIA-E) and ARIA cerebral microhemorrhages (ARIA-H) sites of involvement.

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.

T-Neuro Pharma, a leading biotechnology company dedicated to developing innovative therapies for neurodegenerative diseases, announced today the appointment of Dr. Jeffrey Cummings, MD, ScD as Chair of its Scientific Advisory Board (SAB). Dr. Cummings, a world-renowned expert in Alzheimer's disease research and clinical trials, brings unparalleled expertise to T-Neuro Pharma's mission of advancing early Alzheimer's detection.

Investigational transcranial magnetic stimulation that targeted a brain network involved in memory slowed progression in mild-to-moderate Alzheimer's disease, data from a small phase II study suggested.