Patricia Inacio, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to gantenerumab, a human antibody that’s expected to slow or even prevent cognitive decline and memory loss in Alzheimer’s disease. The FDA designation is intended to accelerate the development and review of candidate therapies with clinical…

Cassava Sciences has launched the first of two Phase 3 clinical trials evaluating the safety and efficacy of simufilam, its investigational oral treatment for Alzheimer’s disease. The second trial is expected to start by year’s end, the company said in a press release. The first Phase 3 trial, called…

The first patient has been dosed in a Phase 1 study that will test multiple ascending doses of ACD856, AlzeCure Pharma‘s lead therapeutic candidate for Alzheimer’s disease. According to a company press release, the trial — the third Phase 1 study testing the oral ACD856 experimental therapy…

A partnership agreement will allow INmune Bio to continue using biomarker imaging technology by Imeka in future clinical trials evaluating XPro1595, the company’s investigational therapy for Alzheimer’s disease. INmune Bio is planning to initiate a Phase 2 study of XPro1595 in Alzheimer’s patients this year, it stated in a…

I-Mab will launch a Phase 1 clinical trial evaluating Protollin, its nasal spray immunotherapy candidate for Alzheimer’s disease. The biotech company’s announcement follows the recent approval of an investigational new drug (IND) application for Protollin by the U.S. Food and Drug Administration (FDA). “Advancing Protollin into clinic is…

Altoida’s artificial intelligence (AI)-powered device, intended to indicate the start of Alzheimer’s disease in adults with mild dementia but no evident disease symptoms, has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA). The non-invasive device uses a software that measures and monitors neurocognitive function to…

A new Phase 3 trial, a collaboration between Eli Lilly and the Banner Alzheimer’s Institute, is planned to evaluate the potential of donanemab in preventing  the cognitive and functional decline related to Alzheimer’s disease. Called TRAILBLAZER-ALZ 3, the study will enroll people with “evidence” of Alzheimer’s but no clinical symptoms.

Gosuranemab, an investigational antibody against the tau protein, failed to meet its primary and exploratory efficacy goals in the TANGO Phase 2 study, its developer, Biogen, has announced. Now, the TANGO trial has been terminated and Biogen will cease the clinical development of gosuranemab as a potential therapy for…

Annovis Bio’s oral therapy ANVS401 (also known as Posiphen) led to significant improvements in cognition in patients with Alzheimer’s disease, according to data from the first patient group in a Phase 2a study. The improvements were also observed in patients with Parkinson’s disease enrolled in the…

ProMIS Neurosciences will advance the development of PMN310, its manmade antibody designed to target the toxic forms of amyloid beta that underlie Alzheimer’s disease. The first step in the manufacturing of PMN310 will be carried out by Selexis with its proprietary CHO-K1 cell line, part of the company’s…