News

The U.S. Food and Drug Administration (FDA) has extended its review period for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease being co-developed by Biogen and Eisai. The three-month extension means the new deadline to review the compound’s biologics license application (BLA), also known as the Prescription…

People with Alzheimer’s disease, as well as their caregivers, are being urged — on social media and via press releases — to get COVID-19 vaccines as soon as possible. That’s the recommendation of the Medical, Scientific and Memory Screening Advisory Board of the Alzheimer’s Foundation of America (AFA). “Getting…

Cognito Therapeutic’s neurostimulation device — a next-generation digital therapeutic designed to treat memory and cognition symptoms in Alzheimer’s disease — has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA). The device, part of a new class of disease-modifying digital therapies, uses proprietary,…

A newly developed technique could make it easier to measure very small concentrations of molecules, which may have implications in early diagnostic testing for Alzheimer’s and other diseases. The technique was described in Research, in the study “Single-Atom Nanozymes Linked Immunosorbent Assay for Sensitive Detection of…

Axsome Therapeutics has launched a Phase 3 trial that will assess the safety and efficacy of AXS-05, the company’s investigational oral treatment for agitation associated with Alzheimer’s disease. If positive, data from the trial is expected to support Axsome’s submission of an application requesting the therapy’s…

Donanemab (LY3002813), Eli Lilly’s experimental antibody-based immunotherapy, slowed cognitive and functional decline in patients at the earlier stages of Alzheimer’s disease, according to data from a Phase 2 trial. Findings from this trial, called TRAILBLAZER-ALZ (NCT03367403), also showed donanemab had a favorable safety profile, which was consistent…

BXCL501, BioXcel Therapeutics’ experimental therapy for the treatment of agitation associated with dementia, was found to be well-tolerated and able to rapidly and sustainably lower agitation in patients with different forms of dementia, including Alzheimer’s disease. These top-line findings from TRANQUILITY, BioXcel‘s Phase 1b/2…

The Alzheimer’s Association and its advocacy affiliate, the Alzheimer’s Impact Movement (AIM), are lauding recent actions by lawmakers that will fund and advance multiple Alzheimer’s disease policies. The advancements are part of the $1.4 trillion government funding bill for the 2021 fiscal year that was passed by Congress on Dec. 21 and…

Novo Nordisk is planning to initiate by midyear a pivotal Phase 3a trial of oral semaglutide, a diabetes treatment, in people with early Alzheimer’s disease. “As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3…

Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40). If cleared by the FDA, it will be among the first commercially available lab tests to…