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…
Conditions
Conditions
Eisai Starting Rolling Submission to FDA for Lecanemab Approval
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…
Hyperbaric Oxygen Therapy Found to Improve Memory in Older People
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…
Dosing Begins in 3rd Phase 1 Study of AlzeCure’s ACD856
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…
1st Phase 3 Simufilam Trial Enrolling Patients; 2nd Expected by Year’s End
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,…
FDA Grants Breakthrough Therapy Designation to Gantenerumab
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…
Safety Board Recommends Trial of Anavex 2-73 Continues as Planned
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…
Nuravax Acquires Rights for MultiTEP Vaccine Platform Tech
Note: This story was updated Oct. 19, 2021, to better reflect the amount by which Nuravax’s vaccines can raise blood antibody levels. The nonprofit Institute for Molecular Medicine (IMM) has licensed its universal vaccine platform technology — called MultiTEP — to Nuravax, a biotech developing therapies for Alzheimer’s disease and other disorders of the central…
Dosing Begins in ACU193 Trial, Targeting Toxic Amyloid Beta
The first patient has been dosed in a Phase 1 trial testing ACU193, an antibody designed by Acumen Pharmaceuticals to target toxic forms of amyloid beta — called amyloid-beta oligomers — as a potential therapy for early Alzheimer’s disease. The INTERCEPT-AD Phase 1 trial (NCT04931459) is expecting to enroll approximately 62 patients, ages 55-85, with mild…
Portable Neurostimulator Safe With Home Use, Alzheimer’s Trial Finds
Use of a portable neurostimulator by Actipulse Neuroscience that delivers fast gamma waves to particular brain regions as a way to stop or slow Alzheimer’s disease was found to be safe in a pilot clinical trial. Another trial focused on testing the device’s effectiveness is expected to open early next year. “We are extremely happy with…
Altoida Starts Five-year Study to Validate Disease-predicting App
Altoida is starting a five-year study to feed its app-based Precision Neurology device with data from thousands of patients across all stages of Alzheimer’s, to help validate the device’s ability to diagnose the disease at the earliest phases. The device will use artificial intelligence (AI) to collect and analyze the results of a series of…
ACT-AD Phase 2 Trial Fully Enrolled with Results Expected Next Year
Athira Pharma has completed enrollment in its ACT-AD Phase 2 trial evaluating the safety and efficacy of ATH-1017 in adults with mild-to-moderate Alzheimer’s disease. “The completion of enrollment in our ACT-AD trial is an important step forward in advancing ATH-1017 as a potential new treatment option for patients suffering from Alzheimer’s and other dementias,” Mark…