The European Medicines Agency (EMA) has agreed to review Biogen and Eisai’s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The companies’ approval request — in the form of a marketing authorization application (MAA) — will be analyzed by the EMA following the usual review timetable for new medications, which can…
Efforts are underway this month to focus attention on Alzheimer’s, a disease that, along with other forms of dementia, affects some 44 million people globally and is swiftly growing in prevalence. During November in the U.S., Alzheimer’s Awareness Month observances include fundraisers, disseminating tips for healthy aging, downloadable Alzheimer’s information, “memory walks,” and information and resources for…
Using levity to battle a serious disease, entertainer Seth Rogen and his wife raised more than $325,000 for HFC, the couple’s national Alzheimer’s disease organization, during its first virtual game show. The funds will help in providing at-home care at no extra charge to Alzheimer’s patients, as well as online support for caregivers. Money will also support brain…
A first patient has been dosed in a Phase 2 trial evaluating the effects of ALZ-801 on disease-related biomarkers in people with early Alzheimer’s disease, who have a specific genetic variant associated with an increased risk of disease progression. “This biomarker study is a key element of our overall Alzheimer’s clinical development program for ALZ‑801,”…
A simple language test, when combined with an artificial intelligence model, can predict which people will develop Alzheimer’s disease later in life, a study shows. This new model predicted Alzheimer’s seven years before its diagnosis with an accuracy of 70%, according to the study. That rate is higher than those attained by traditional predictive methods,…
RetiSpec and Gentex are partnering to develop a technology to detect Alzheimer’s disease — potentially years before symptom onset — using a non-invasive and cost-effective eye scan technique. The partnership between the two companies will expedite the development of the technology, with the goal of bringing it to market to advance patient care. “The Gentex-RetiSpec partnership…
A first patient has been dosed in a Phase 2 trial investigating the safety and long-term efficacy of bryostatin-1 in treating moderate and moderately severe Alzheimer’s disease, the therapy’s developer, Neurotrope, announced. The trial (NCT04538066), which is recruiting patients at several sites across the U.S., will build on data from previous studies assessing bryostatin-1. Specifically, it…
GemVax & KAEL has filed for expanded access of its U.S. Food and Drug Administration (FDA) investigational new drug (IND) application for GV1001, its experimental treatment for Alzheimer’s disease. The company is seeking to include additional investigational groups in its clinical development program. The filing comes following positive results of a Phase 2 clinical trial…
Dosing of patients has begun in a Phase 2/3 clinical trial evaluating ATH-1017, Athira Pharma‘s investigational candidate for the treatment of mild to moderate Alzheimer’s disease. “Embarking on this trial to evaluate our new approach to treating Alzheimer’s is the start of a collective experience that will involve not only individuals with Alzheimer’s but their…
Semorinemab, a monoclonal antibody against phosphorylated tau, failed to significantly alter dementia’s progression in people with early Alzheimer’s disease (AD) taking part in a Phase 2 clinical trial. The investigational therapy, which is being jointly developed by AC Immune and Genentech (a Roche company), also failed to meet secondary trial goals related to cognition and…
