In The News: Department of Brain Health
On Nov. 7, 2024, the U.S. Food and Drug Administration (FDA) granted icometrix clearance for icobrain aria, the first AI software approved for detecting, measuring and grading amyloid-related imaging abnormalities (ARIA), a potentially harmful side effect of new amyloid-targeting therapies. A large study, needed for FDA clearance, demonstrated that the use of icobrain aria significantly increases the accuracy of ARIA assessments by radiologists and hence allows for safer use of new amyloid-beta targeting therapies for Alzheimer’s disease patients.
T-Neuro Pharma, a leading biotechnology company dedicated to developing innovative therapies for neurodegenerative diseases, announced today the appointment of Dr. Jeffrey Cummings, MD, ScD as Chair of its Scientific Advisory Board (SAB). Dr. Cummings, a world-renowned expert in Alzheimer's disease research and clinical trials, brings unparalleled expertise to T-Neuro Pharma's mission of advancing early Alzheimer's detection.
Investigational transcranial magnetic stimulation that targeted a brain network involved in memory slowed progression in mild-to-moderate Alzheimer's disease, data from a small phase II study suggested.
Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease. Previously, an exploratory microdose clinical trial in healthy volunteers demonstrated successful activation of PRX-P4-003 upon oral administration, the intended therapeutic route.
The Alzheimer's Drug Discovery Foundation (ADDF) will be leading a roundtable, "Advancing Combination Therapy: Discussion on Key Considerations, Perspectives, and Promising Avenues for the Future of Alzheimer's Treatments," at the 2024 Clinical Trials on Alzheimer's Disease (CTAD) conference, which will be held October 29th through November 1st in Madrid, Spain.
The Alzheimer's Drug Discovery Foundation (ADDF) today announced a new investment to develop a first-of-its-kind Biomarker Observatory that will provide a comprehensive overview of the Alzheimer's biomarkers pipeline, including blood tests, brain scans, digital devices, and other tools that can help diagnose and monitor the disease. These efforts will be led by renowned clinical trialist Jeffrey Cummings, MD, ScD, Joy Chambers-Grundy Professor of Brain Science at the School of Integrated Health Sciences at University of Nevada, Las Vegas with Co-Principal Investigator Feixiong Cheng, PhD, from the Laboratory of Network Medicine at Cleveland Clinic. This Observatory will fill a critical gap by creating the first thorough overview of the biomarker pipeline, serving as a key resource to catalyze progress in drug development.
Today, Global Alzheimer’s Platform Foundation® (GAP) and the University of Nevada, Las Vegas (UNLV), announced a memorandum of understanding (MOU) regarding a collaboration to accelerate research for neurodegenerative diseases. This includes establishing a state-of-the-art imaging and emerging technology program dedicated to the development and implementation of new and innovative biomarker and diagnostic solutions for central nervous system (CNS) research.
Over the past two years, Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla, both anti-amyloid antibodies, made history as the first real options to slow cognitive decline associated with Alzheimer’s disease. For years, amyloid plaques and tau tangles have been a primary target of Alzheimer’s disease research and drug development, but while affecting these proteins may yield some benefit, the illness continues to progress. Today, multiple therapeutics are in Phase III trials with other targets, suggesting that within the next few years it may become possible to treat Alzheimer’s via multiple pathways.
AXS-05, a novel NMDA receptor antagonist that already has approval for major depressive disorder, shows significant benefit in the treatment of agitation that is associated with Alzheimer’s disease, according to research presented at the 2024 Alzheimer’s Association International Conference (AAIC).
On Sunday, the Alzheimer’s Association kicks off its international conference and there’s already buzz about a blood test that is between 85% and 90% accurate in identifying Alzheimer’s disease. Having an easy blood test could be game changing. Right now, the only way to confirm an Alzheimer’s diagnosis is with a costly PET scan or an invasive spinal puncture.
The FDA has granted both Fast Track and Regenerative Medicine Advanced Therapeutic (RMAT) Designations to Longeveron's Lomecel-B investigational allogeneic medicinal signaling cell (MSC) therapy for the potential treatment of patients with Alzheimer disease (AD).1,2.
For Dr. Jeffrey Cummings, a brain health researcher and professor at UNLV, this is an exciting time in the fight against Alzheimer’s disease. Federal health advisers in May voted to back an Alzheimer’s drug from Eli Lilly and Co. that can slow the progression of cognitive decline and memory problems. On Tuesday morning the drug — donanemab — gained final approval from the U.S. Food and Drug Administration, making it the second Alzheimer’s drug that slows cognitive decline cleared for use in the United States.