News

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…

One year of treatment with ALZ-801 (valiltramiprosate) was found in a Phase 2 trial to improve cognition and lower the levels of disease biomarkers among people with early Alzheimer’s with one or two copies of the apolipoprotein E4 (APOE4) disease-associated genetic variant. Importantly, the investigational therapy from…

Nearly half of Alzheimer’s disease patients treated with TrueBinding’s investigational therapy TB006 for at least three months showed signs of disease reversal or cognitive improvement, according to data from an open-label extension (OLE) study. The findings expand on data from a completed Phase 2a trial (NCT05074498) that…

An innovation passport, the first step in the U.K.’s Innovative Licensing and Access Pathway (ILAP) — intended to accelerate the development and approval of new therapies that address an unmet medical need — has been awarded to AD04, ADvantage Therapeutics’ investigational immunotherapy for mild Alzheimer’s disease. The designation, granted…

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,…

Cognitive benefits were reported in nearly half of the Alzheimer’s disease patients given simufilam for one year in a clinical trial, while those with early-stage, mild disease appeared to respond best to the experimental medication. That’s according to top-line data from the open-label Phase 2 study (NCT04388254) in 216…

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…