Biogen and Eisai are stepping up their Phase 4 post-marketing confirmatory study to verify that Aduhelm (aducanumab) is meeting the expected clinical benefit in patients with early-stage Alzheimer’s disease. The companies plan to submit the study’s final protocol for review to the U.S. Food and Drug Administration (FDA) in March. The study will be aiming to…
Annovis Bio’s oral therapy ANVS401 lessened the accumulation of toxic forms of amyloid-beta and tau protein — two hallmarks of Alzheimer’s disease — and led to significant improvements in cognition in patients with early Alzheimer’s, data from a Phase 2a study show. Moreover, ANVS401 levels in the blood were in agreement with previous studies and the…
BioXcel Therapeutics has launched a pivotal Phase 3 trial program to continue to evaluate BXCL501, its oral experimental candidate for the treatment of agitation in patients with Alzheimer’s disease. The new program consists of two clinical trials — TRANQUILITY II and TRANQUILITY III — and will assess the safety and efficacy of BXCL501 in adults…
The Committee for Medicinal Products for Human Use, or CHMP, is recommending that Aduhelm (aducanumab) should not be approved to treat the early stages of Alzheimer’s disease. The CHMP, which is part of the European Medicines Agency (EMA), voted against recommending Aduhelm last month, and now has issued its formal ruling. The decision comes despite…
Alzheimer’s Research UK said it “welcomes” a plan by the Football Association (FA) and other soccer governing entities to better understand and promote brain health in English football, calling the new efforts to protect players “a step forward.” In addition to the Football Association’s research task force, the joint action plan was produced by the…
I-Mab Biopharma announced that the first patient has been dosed in the U.S.-based Phase 1 trial of its intranasal immunotherapy agent Protollin — an investigational medication being developed to treat those with early Alzheimer’s disease. The U.S. Food and Drug Administration approved the company’s request for this safety and early efficacy study in July. “This is an…
To honor their grandmother who died from Alzheimer’s in 2011, two sisters have written a children’s book to explain to kids what the disease is and how it affects those who have it. Tanya Iovino and Kiki Kouris wrote “A Kids Book About Alzheimer’s” to provide support and information to people who have a family…
Athira Pharma announced its Phase 2 ACT-AD trial is fully enrolled and its Phase 2/3 LIFT-AD trial has reached more than half of its target number. Both studies are evaluating the safety and efficacy of ATH-1017 in people with mild to moderate Alzheimer’s disease. Eligible adults, ages 55 to 85, are still being recruited for…
When Enma Espinosa worked during the day and her husband, Francisco Espinosa, worked the night shift, they barely saw each other. So it took longer for her to realize the small changes in his cognition were not just a normal part of aging. It wasn’t until her husband’s barber called to inform Espinosa that he…
A coalition of dementia organizations is calling on the U.K. government to help care-home residents maintain physical contact with loved ones during the COVID-19 pandemic. Called One Dementia Voice, the coalition acknowledges the difficulties of balancing the risk of COVID-19 against the potential harm done by isolation. However, it is seeking to have the government…
