News

Eisai has started submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in support of an application for approval of its investigational lecanemab (BAN2401) to treat early Alzheimer’s disease. This submission followed the company’s prior assessment consultation with the PMDA, given in advance of an approval application and intended…

Roche is launching a Phase 3 clinical trial to evaluate the ability of its investigational antibody therapy, gantenerumab, to slow Alzheimer’s progression in people with early signs of the disease, the company announced. Called SKYLINE (NCT05256134), the trial is now recruiting 1,200 cognitively unimpaired participants between…

LX1001, a one-time gene therapy for Alzheimer’s disease being developed by Lexeo Therapeutics, raised levels of the protective APOE2 protein in the cerebrospinal fluid (CSF), early data from an ongoing Phase 1/2 trial shows. Findings in a first patient group treated at low dose also showed the gene therapy reduced the…

A clinical trial application for varoglutamstat, or PQ912, an investigational therapy for Alzheimer’s disease, was approved in China, its developers, Vivoryon Therapeutics and Simcere Pharmaceutical Group, announced. “We are proud to have obtained [China’s Center for Drug Evaluation] CDE approval of our Clinical Trial Application of varoglutamstat…

A biomarker blood test called AlzoSure Predict that can help to identify people with mild cognitive impairment who are likely progress to Alzheimer’s disease — years before symptoms are evident — has been approved for use in the European Union (EU) and the U.K., its marketer, Diadem, announced. “This…

Improved access to high-quality healthcare and research for Latinos living with Alzheimer’s disease and related dementia are needed, according to a summary report from the second Latinos & Alzheimer’s Symposium. Understanding underlying disease-related processes unique to Latino populations, and identifying social and environmental risk factors for this group also…

Fosgonimeton, an experimental therapy Athira Pharma is developing to treat Alzheimer’s disease, was well-tolerated overall in a Phase 1 clinical trial that included Alzheimer’s patients as well as healthy volunteers. “These encouraging results showed a positive safety and tolerability profile of fosgonimeton across a wide dose range,” Hans Moebius,…

Although the vast majority of older Americans are concerned about Alzheimer’s disease, most are unaware of Aduhelm (aducanumab), the recently approved treatment for the disease, according to a survey study. “The contrast between older Americans who were very concerned about developing Alzheimer’s disease and those that actually knew…

ACI-35.030, an experimental anti-tau vaccine that AC Immune is developing for Alzheimer’s disease, was able to potently induce an immune response as intended and was generally well-tolerated, according to 10-week interim data from a Phase 1/2 clinical trial. “These latest interim results add to the robust clinical dataset…

The Alzheimer’s Association is funding research that aims to improve the lives of caregivers as well as the dementia patients they serve. Amanda Leggett, PhD, a research assistant professor at the University of Michigan, has been awarded $150,000 by the U.S. nonprofit’s Dementia Care Provider Roundtable (AADCPR) to support…