Marisa Wexler, MS, senior science writer —

Eisai and Biogen are seeking approval in Canada and the U.K. for lecanemab to treat early Alzheimer’s disease. It’s available under the name Leqembi in the U.S. Health Canada has accepted the application for review, while the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA)…

Donanemab significantly slowed the decline of cognitive and functional abilities in people with early Alzheimer’s disease, according to top-line data from a Phase 3 clinical trial. Based on these findings, Eli Lilly, its developer, plans to ask the U.S. Food and Drug Administration (FDA) to approve it within the…

The U.S. Food and Drug Administration (FDA) has approved Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. With this approval, Rexulti has now become the first and only therapy ever approved for this specific indication in the U.S. “Today marks a major milestone for…

Eli Lilly’s donanemab was found to work better than Aduhelm (aducanumab) in a biomarker study of people with early Alzheimer’s in removing disease-associated toxic protein clumps in the brain. The experimental therapy outperformed the approved treatment, from Eisai and Biogen, in a Phase 3 clinical trial, according…

Treatment with the experimental therapy BIIB080 led to long-term reductions in the levels of disease-associated tau protein in the brains of people with early Alzheimer’s disease. That’s according to new data from a Phase 1b trial (NCT03186989) presented by Biogen at the International Conference on Alzheimer’s and Parkinson’s…

Alzamend Neuro has completed the clinical portion of a Phase 2 trial testing AL001, an investigational formulation of lithium that the company is developing to treat Alzheimer’s disease and other disorders. Data from the trial now will be collected and analyzed. Top-line results are expected by this summer,…

The U.S. Food and Drug Administration (FDA) has agreed to review a request to convert Leqembi’s (lecanemab) accelerated approval to a traditional approval for treating Alzheimer’s disease. The FDA has granted priority review to the supplemental biologics license application (sBLA) and the agency is expected to make a…

The U.S. Food and Drug Administration (FDA) will consider brexpiprazole to treat agitation in people with Alzheimer’s disease. The supplementary new drug application, submitted by developers Otsuka Pharmaceutical and Lundbeck, has been granted priority review by the FDA, shorting its review time from the standard 10 months…

Treatment with lecanemab (BAN2401), an experimental amyloid-targeting antibody, significantly slowed the progression of dementia symptoms among people with early Alzheimer’s disease in the Phase 3 Clarity AD clinical trial, Biogen and Eisai announced. Both companies, the therapy’s developers, plan to discuss these results with regulatory authorities in the U.S.,…

Trametinib, an oral medication approved to treat certain cancers, improved cognition and neuronal health in a mouse model of Alzheimer’s disease, according to a new study. Data suggest the treatment helped to clear toxic protein aggregates from nerve cells. The study, “MEK1/2 inhibition rescues neurodegeneration by TFEB-mediated activation…