Marisa Wexler, MS, senior science writer —

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…

Two Phase 3 clinical trials are testing the effectiveness of simufilam, an experimental oral therapy that’s designed to improve cognition in people with Alzheimer’s disease. Top-line results from the RETHINK-ALZ trial (NCT04994483) are expected by the end of this year,…

Biogen is discontinuing development and commercialization of its controversial Alzheimer’s disease treatment Aduhelm (aducanumab) — a move that’s “not related to any safety or efficacy concerns,” the company said in a press release. Instead, according to Christopher Viehbacher, president and CEO of Biogen, the company is…

A commercially available blood test, sold by ALZpath, can identify with high accuracy Alzheimer’s disease patients who are likely to be eligible for new treatments, a study suggests. By detecting a version of the tau protein in a blood sample, the “ALZpath pTau217 test can help healthcare providers…

The cell therapy candidate Lomecel-B significantly improved cognitive function and reduced brain volume loss relative to a placebo in a Phase 2a clinical trial of people with mild Alzheimer’s disease, according to new data announced by the treatment’s developer Longeveron. “We believe these new data may provide evidence…

A rare variant in the APOE gene, known as the Christchurch mutation or APOE3ch, can protect against the development of Alzheimer’s disease by stopping the spread of toxic clumps of the tau protein in the brain, a new study suggests. The findings may have implications for better understanding Alzheimer’s underlying…