Marisa Wexler, MS,  senior science writer—

Axsome Therapeutics plans this year to ask the U.S. Food and Drug Administration (FDA) to approve its oral therapy AXS-05 as a treatment for agitation related to Alzheimer’s disease. The company recently announced results from two Phase 3 trials testing AXS-05. One study, ACCORD-2, hit its…

November is National Alzheimer’s Awareness Month, and the Alzheimer’s Foundation of America (AFA) is encouraging those impacted by Alzheimer’s disease — and their supporters — to wear teal and spread the word on social media to educate people. The AFA notes on its website that it selected…

Alzamend Neuro has determined the maximum tolerated dosage of AL001, its experimental lithium therapy for Alzheimer’s disease and other disorders, that will be used in future clinical trials. The identified dose is unlikely to require the type of intensive drug monitoring that has been a major hurdle to the…

Treatment with CT1812, previously called Elayta, slowed the decline of cognitive function among adults with mild to moderate Alzheimer’s disease in a proof-of-concept clinical trial dubbed SHINE. That’s according to results seen after approximately six months of treatment in the Phase 2 SHINE study (NCT03507790) at…

The U.S. Food and Drug Administration (FDA) has approved the oral therapy Zunveyl (benzgalantamine), previously known as ALPHA-1062, to treat mild-to-moderate Alzheimer’s disease. “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral [Alzheimer’s] treatment…

The safety and effectiveness of oral therapy candidate buntanetap are comparable in people with early Alzheimer’s disease regardless of whether they do or do not carry a genetic risk factor known as APOE4. That’s according to new data from a Phase 2/3 clinical trial (NCT05686044) that tested…

The U.S. Food and Drug Administration (FDA) has agreed to review a supplemental application seeking authorization of once-monthly maintenance dosing for Leqembi (lecanemab), an approved treatment for early Alzheimer’s disease. A decision from the agency is expected by Jan. 25, 2025, according to a press release from…

An advisory committee to the U.S. Food and Drug Administration (FDA) has unanimously voted in favor of donanemab, an anti-amyloid therapy developed by Eli Lilly that’s currently up for approval as a treatment for early Alzheimer’s disease. All members of the FDA’s Peripheral and Central…

Eisai has started a rolling application seeking U.S. approval of a subcutaneous, or under-the-skin, injection version of Leqembi (lecanemab) for maintenance dosing in people with early Alzheimer’s disease. This formulation of the approved intravenous (into-the-vein) medication is expected to reduce the treatment burden for patients, if granted…

A U.S. Food and Drug Administration (FDA) advisory committee will meet June 10 to review clinical trial data related to donanemab, Eli Lilly‘s experimental anti-amyloid therapy, according to a company press release. The FDA is reviewing Lilly’s application seeking approval of donanemab to treat early Alzheimer’s…