Margarida Maia, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Quanterix’s experimental blood test measuring p-Tau 217, the protein that builds up as toxic tangles in the brains of people with Alzheimer’s disease. The test, Simoa p-Tau 217, has the potential to help doctors diagnose…

A Phase 3 clinical trial of AVP-786 failed to meet its main goal of easing agitation in adults with dementia due to Alzheimer’s disease, said sponsor Otsuka Pharmaceutical. The clinical trial (NCT03393520), also dubbed 17-AVP-786-305, tested AVP-786’s safety in addition to evaluating its effectiveness compared with a…

T3D-959, an oral medication in the pipeline of T3D Therapeutics, outperformed a placebo at improving cognitive function in people with mild to moderate Alzheimer’s disease who have a high pTau-217/Non-pTau-217 ratio, a new marker of the disease. That’s according to top-line results from the Phase 2…

The U.S. Food and Drug Administration (FDA) has granted full approval to Eisai and Biogen’s Leqembi (lecanemab), the first treatment shown to slow disease progression in adults with early Alzheimer’s disease. Leqembi won accelerated (conditional) approval in January based on Phase 2 trial data that showed it…

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…

INmune Bio received the green light for MINDFul, its Phase 2 trial of XPro1595 — an experimental treatment for Alzheimer’s disease — to begin in Canada. Health Canada, Canada’s regulatory health authority, issued a “no objection letter” where it gives the company official permission to test XPro1595 in…

Acumen Pharmaceuticals’ investigational antibody ACU193 has been granted fast track status by the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. With this designation, the company is eligible for certain benefits to get a potential new treatment…

COR588, Quince Therapeutics’ investigational oral small molecule for mild to moderate Alzheimer’s disease, appears to be safe and well tolerated, according to results from a Phase 1 trial, the company announced. (The company was known as Cortexyme until Aug. 1.) The recently completed single and multiple ascending dose clinical…

The Einstein Aging Study has received a $32 million grant from the National Institutes of Health (NIH) to delve into the many risk factors that may determine cognitive decline and disease progression in people with Alzheimer’s. The study, ongoing at the Albert Einstein College of Medicine since…

A dual vaccine targeting both amyloid plaques and tangled fibers made up of tau — two abnormal protein aggregates that build up in the brain of those with Alzheimer’s — may have potential to treat and prevent the disease. Prothena, its developer, has found preclinical evidence that the…