Patricia Inacio, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Phospho-Tau 217 (pTau217), a blood-based biomarker test that can help distinguish Alzheimer’s disease from other neurodegenerative disorders. The test, developed by Roche in collaboration with Eli Lilly, is intended to support a more accurate…

A proof-of-concept Phase 2b clinical trial evaluating the safety and efficacy of Advantage Therapeutics’ investigational immunotherapy AD04 in people with mild Alzheimer’s disease has enrolled its first patient. The placebo-controlled study is being conducted in Austria, France, Poland, Bulgaria, and Slovakia, and is expected to open clinical sites in Germany and…

Alzamend Neuro is seeking regulatory approval to launch the first U.S. trial of ALZN002, its investigational vaccine for mild to moderate dementia related to Alzheimer’s disease. If the U.S. Food and Drug Administration (FDA) approves the company’s investigational new drug application (IND), Alzamend will start a Phase 1/2a…

The U.S. Food and Drug Administration (FDA) has greenlit Annovis Bio to conduct a Phase 2/3 trial to test its investigational treatment buntanetap in people with moderate Alzheimer’s disease. The study, expected to start later this year, follows the positive findings from a Phase 2a trial…

Alpha Cognition’s candidate oral tablet ALPHA-1062, for mild to moderate Alzheimer’s disease, showed efficacy as a bioequivalent substitute for the approved therapy Razadyne (galantamine), according to top-line data from a trial with healthy volunteers. Per this new data, as a delayed-release tablet, ALPHA-1062 showed…

The U.S. Food and Drug Administration (FDA) has kept to its initial decision to reject a request by Acadia Pharmaceuticals to expand Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease-related psychosis. In a complete response letter (CRL) indicating it had finished its review of the…

A large clinical trial has received $45 million in U.S. funding to evaluate the efficacy of benfotiamine — a lab-made precursor of thiamine or vitamin B1 — in slowing the cognitive decline of those with mild Alzheimer’s disease or mild cognitive impairment. The five-year grant was awarded by the…

ALPHA-1062, Alpha Cognition’s investigational oral tablet for mild to moderate Alzheimer’s disease, may be a bioequivalent substitute for the approved therapy Razadyne, according to a pivotal trial with healthy volunteers. The pro-drug therapy — meaning that the medication is metabolized in the body, after administration — showed positive…

Early treatment with crenezumab, an investigational anti-amyloid antibody, failed to significantly slow or prevent cognitive decline in a group of people with a genetic risk for early-onset Alzheimer’s disease, data from a Phase 2 trial show. Numerical differences favoring crenezumab over a placebo were seen across…

A Phase 2 clinical trial will test BMND08, an investigational oral therapy based on a natural psychedelic, in treating depression and anxiety in people with Alzheimer’s disease, its developer, Biomind Labs, reported. The company’s announcement follows the trial’s approval by an institutional review board in Argentina.