The Einstein Aging Study has received a $32 million grant from the National Institutes of Health (NIH) to delve into the many risk factors that may determine cognitive decline and disease progression in people with Alzheimer’s. The study, ongoing at the Albert Einstein College of Medicine since 1980, focuses on the brain and how it…
Category: Blog
Dosing Begins for Next Phase of Trial for Investigational Therapy AL001
Alzamend Neuro has dosed the first patient in the multiple ascending dose portion of its Phase 2a clinical trial of AL001, an investigational oral therapy for dementia related to Alzheimer’s disease. This multiple ascending dose (MAD) part follows positive results from a Phase 1 trial. Topline data from the Phase 2a trial is expected in…
Fujirebio’s Diagnostic Test for Beta-amyloid Plaques Given FDA OK
The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease. The Lumipulse G β [beta]-Amyloid Ratio (1-42/1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults ages 55 and up who are being evaluated…
Eisai Completes Rolling Submission to FDA for Lecanemab Approval
Eisai has completed a rolling submission to the U.S. Food and Drug Administration (FDA) to seek approval for lecanemab (BAN2401), an investigational antibody for the treatment of early Alzheimer’s disease accompanied by beta-amyloid deposits in the brain. The request — made in the form of a biologics license application (BLA) — if accepted by the…
Treatment Lowers Toxic Amyloid-beta Levels in Mouse Brain Cells
An investigational gamma-secretase modulator designed for the treatment of Alzheimer’s disease led to an efficient and long-lasting reduction of toxic amyloid-beta 42 peptide in cell cultures and mouse brain cells, according to data from a recent study. In mice, the compound, called AC-0027875, was also able to penetrate the brain in high concentrations, which is…
Ninlaro as Oral Combo Therapy Fails at Trial in Heavily Treated Patients
Adding Ninlaro (ixazomib) to cyclophosphamide and dexamethasone does not improve progression-free survival for multiple myeloma patients who relapsed after several lines of treatment, a Phase 2 trial reported. The study, “Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled trial results,” was published in the journal Blood Cancer Journal.…
FDA Committee to Review Nuplazid in Treating Alzheimer’s Psychosis
A U.S. Food and Drug Administration (FDA) advisory committee will host a virtual meeting to review a request to expand the approval of Nuplazid (pimavanserin) to include psychosis due to Alzheimer’s disease dementia. The FDA’s Psychopharmacologic Drugs Advisory committee meeting on the application recently submitted by Acadia Pharmaceuticals, which developed and markets Nuplazid, is scheduled for June 17. The committee’s decision…
Biogen Scraps Infrastructure for Aduhelm Sales in US
Biogen is eliminating corporate infrastructure that had been put in place to support sales of Aduhelm (aducanumab) in the U.S., the company announced. The decision is being made in response to a policy announced last month that Medicare would only cover the cost of Aduhelm for people with Alzheimer’s disease enrolled in select clinical trials.…
‘Good’ Cholesterol in Brain May Aid Cognition, Help Prevent Alzheimer’s
Higher levels of small high-density lipoprotein (HDL), known as “good cholesterol,” in the fluid surrounding the brain and spinal cord associated with a better performance on cognitive tests in older adults, a study reported. Confirmation of a link between good cholesterol levels and cognitive outcomes in larger groups could lead to new biomarkers of Alzheimer’s disease and…
Agreement Reached to Develop MMP-13 Inhibitors to Treat Myeloma
SteroTherapeutics has entered into an exclusive license agreement with Moffitt Cancer Center and Florida Atlantic University Research Corporation to develop matrix metalloproteinase 13 (MMP-13) inhibitors for treating multiple myeloma. “This partnership with Moffitt Cancer Center and the Research Institute of Florida Atlantic University will allow us to further develop this novel line of highly selective MMP-13…