After reviewing interim trial data, an independent safety board has recommended that Anavex Life Sciences continues a trial, without modification, of its oral therapy Anavex 2-73 (blarcamesine) in people with early Alzheimer’s disease. The board made a similar recommendation after an interim analysis earlier this year. Such a committee comprises a group of external experts tasked with…
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 evidence of substantial improvement over approved treatments…
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 RETHINK–ALZ (NCT04994483), aims to enroll around 750 people,…
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 — is proceeding according to plan, with results…
Hyperbaric oxygen therapy (HBOT) — treatment in which patients are given pure oxygen — prevented the biological processes responsible for the development of Alzheimer’s disease in a mouse model, a study found. Moreover, in a group of older people with memory loss, such oxygen therapy enhanced blood flow in the brain and improved overall cognitive…
Eisai has started work on a rolling submission to the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab (BAN2401), its antibody treatment for early Alzheimer’s disease. As a rolling submission, Eisai will submit each portion of its application as it is completed, rather than waiting for its entire package…
Treatment with the investigational anti-tau monoclonal antibody semorinemab significantly slowed decline in a measure of cognition among people with mild-to-moderate Alzheimer’s disease in the Phase 2 LAURIET clinical trial, top-line results show. “The top line results of the Lauriet Phase 2 clinical trial of semorinemab are remarkable in that it is the first time we…
Athira Pharma, Inc will initiate an open-label extension study for two ongoing clinical trials investigating ATH-1017 to treat Alzheimer’s disease. Both clinical trials — the Phase 2/3 LIFT-AD (NCT04488419) and Phase 2 ACT-AD (NCT04491006) — are investigating ATH-1017, a small molecule designed to enhance the effect of hepatocyte growth factor (HGF), and its receptor, MET. Both are expressed in the…
People affected by Alzheimer’s disease and related dementias are invited to register for the Mayo Clinic Conference on Brain Health and Dementia, which also pays tribute to all that the community has been going through during the COVID-19 pandemic. Held virtually on Oct. 29 from 9:15am to 2:15pm CDT, the free event is a collaboration…
A new documentary released in advance of World Alzheimer’s Day today tells the story of a Worcester, Massachusetts, photographer and art professor who captured the gradual cognitive decline of his late father through a large format black-and-white camera. “With Dad,” which is available to stream on the local Boston TV and radio station website GBH…
