Latest news with #Alzheimer's-associated
Business Wire
4 days ago
- Health
- Business Wire
Applied Cognition Publishes First-in-Human Study of Glymphatic Function in Nature Biomedical Engineering
SAN FRANCISCO--(BUSINESS WIRE)-- Applied Cognition, a clinical-stage platform therapeutic company, today announced the publication of a groundbreaking study in Nature Biomedical Engineering demonstrating the first continuous, non-invasive measurement of human glymphatic function—the brain's system for clearing waste, including Alzheimer's-associated proteins like amyloid and tau. Working with researchers at the University of Florida and the University of Washington School of Medicine, the company validated its novel multimodal electrical impedance spectroscopy device using contrast-enhanced MRI. The platform also revealed, for the first time in humans, how EEG and cardiovascular physiology contribute to sleep-active glymphatic activity. 'This work is pivotal in defining the role glymphatic dysfunction plays in Alzheimer's and discovering therapies to rescue it,' said Dr. Paul Dagum, CEO and co-founder of Applied Cognition. 'Our platform has already identified a promising drug candidate that improves glymphatic clearance in early clinical trials.' Originally characterized in rodents, the glymphatic system plays a vital role in the removal of toxic proteins. Until now, studying its function in humans has been limited to slow, high-cost MRI scans. Applied Cognition's technology offers a scalable solution that allows real-time, remote, and high-resolution tracking, enabling new avenues for drug discovery. Co-author on this study was Dr. Jeffrey Iliff, PhD, Psychiatry, University of Washington School of Medicine, who along with Dr. Maiken Nedergaard at the University of Rochester Medical Center characterized the glymphatic system in rodents. 'This unlocks our ability to study glymphatic function in the real world and with high-temporal resolution, not just the MRI suite, giving us new mechanistic insights of its role in neurological and psychiatric conditions,' said Dr. Iliff. Piyush Jain, Head of New Products at Genentech, added: 'Applied Cognition is bridging the gap between lab science and patient care. Their platform is accelerating the discovery of drugs that target the clearance of misfolded proteins at the root of devastating neurological diseases." Applied Cognition is advancing its lead drug program for early-stage Alzheimer's and expanding its pipeline across neurodegenerative and psychiatric disorders. The paper's authors include Paul Dagum, Laurent Giovangrandi, Swati Rane Levendovszky, Jake J. Winebaum, Tarandeep Singh, Yeilim Cho, Robert M. Kaplan, Michael S. Jaffee, Miranda M. Lim, Carla Vandeweerd, and Jeffrey J. Iliff. About Applied Cognition Applied Cognition is clinical-stage platform therapeutics company advancing the brain's glymphatic system to drug development. Enhancing glymphatic function is a promising new therapeutic strategy for treating neurodegenerative diseases. Using its first-in-class platform, which enables continuous monitoring of glymphatic activity in humans, the company has successfully identified the first therapeutic target and lead drug candidate to enhance glymphatic clearance of amyloid and tau. Applied Cognition is currently advancing this lead program for early-stage Alzheimer's and expanding its pipeline to explore treatments for other conditions using its platform.
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Business Standard
21-05-2025
- Health
- Business Standard
Alzheimer's diagnosis with blood test becomes reality: All you need to know
Lumipulse G pTau217/ß-Amyloid 1-42: USFDA has approved the first-ever blood test to help diagnose Alzheimer's disease, offering a faster, less invasive, and more affordable way to detect early signs Barkha Mathur New Delhi The US Food and Drug Administration (FDA) has approved the first-ever in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease. Set to launch in June 2025, the test offers a faster, more accessible, and less invasive alternative to PET scans and spinal taps, especially for people showing early signs of memory loss and cognitive decline. It has been granted 'Breakthrough Device' designation by the FDA, reflecting its potential to significantly improve Alzheimer's detection and care. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Martin A Makary in a statement. 'Knowing that 10 per cent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' What is the Lumipulse blood test and how does it work? Developed by Fujirebio Diagnostics, the test is called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. It measures the ratio of two key biomarkers in the blood—β-amyloid 1-42 and β-amyloid 1-40—both of which are linked to the buildup of amyloid plaques in the brain, a defining feature of Alzheimer's disease. Who can take Alzheimer's blood test and when should it be used? The test is intended for adults aged 55 and older who are showing early signs of cognitive decline, such as memory loss or confusion. It is not a screening tool for asymptomatic individuals and is not available over the counter. The FDA emphasised that the test should support, not replace, a doctor's clinical assessment. It requires a physician's referral and is not meant for standalone diagnosis. What are the current ways Alzheimer's is diagnosed? Traditional diagnostic methods include: Cognitive tests and memory assessments Brain scans such as MRI or PET Spinal taps for cerebrospinal fluid (CSF) analysis These tests can be costly, invasive, and are not always covered by insurance—especially in developing countries. How accurate is the Alzheimer's blood test compared to current diagnostic methods? In a clinical trial involving 499 patients, the test demonstrated high diagnostic reliability: 91.7 per cent of people with positive results had Alzheimer's-associated plaques confirmed by PET scans or spinal taps 97.3 per cent of those with negative results had no plaques This level of accuracy could significantly reduce the need for expensive and invasive PET imaging or lumbar punctures. When and where will the Alzheimer's test be available? Fujirebio has confirmed that the test will be available in certified laboratories across the United States starting June 2025. It will not be sold directly to consumers and will require a physician's order. How can this test impact Alzheimer's treatment? Early diagnosis allows earlier intervention, which is critical to slowing the progression of Alzheimer's disease. This test could help doctors identify candidates for drugs like Leqembi (lecanemab) and Kisunla (donanemab) before significant brain damage occurs. A positive test result indicates the presence of amyloid plaques but does not confirm Alzheimer's on its own. False positives and negatives are possible, and results must be interpreted alongside other clinical evaluations. Why this matters for Alzheirmer's patients and caregivers This new blood test marks a significant breakthrough in making Alzheimer's diagnosis more accessible and less burdensome. For families and patients, it could mean earlier answers, targeted treatments, and improved planning for the future. For more health updates, follow #HealthWithBS
