icometrix, a global leader in AI-driven software for brain imaging, has announced that its icobrain aria has received FDA clearance on November 7, 2024. This marks the first AI software approved for detecting, measuring, and grading amyloid-related imaging abnormalities (ARIA), a potentially harmful side effect associated with new amyloid-targeting therapies for Alzheimer’s disease. The FDA clearance was supported by a large study demonstrating that icobrain aria significantly increases the accuracy of ARIA assessments by radiologists, thereby promoting safer use of amyloid-beta targeting therapies.
Improving ARIA Detection with AI
Amyloid-lowering treatments represent a significant advancement in Alzheimer’s disease treatment but carry the risk of ARIA, characterized by brain swelling and haemorrhage. According to Prof. Stephen Salloway, Butler Hospital and Professor of Neurology and Psychiatry at the Warren Alpert Medical School of Brown University, standardized tools like icobrain aria are needed to assist radiologists and clinicians in detecting and managing ARIA to optimize patient safety. The software is designed to work in the background, automatically generating an overview report on the ARIA assessment for radiologists using standard clinical MRI scans.
Addressing a Critical Need in Alzheimer's Treatment
The FDA’s clearance of icobrain aria arrives when new Alzheimer’s treatments are reshaping care options in the United States. Aducanumab (Aduhelm) was the first FDA-approved drug in 2021 intended to slow Alzheimer’s progression by reducing amyloid plaques in the brain. It was followed by other therapies, including lecanemab (Leqembi) and donanemab (Kisunla), each designed to target amyloid buildup. These treatments represent a shift from symptom management to disease-modifying approaches.
However, these therapies carry risks, including the development of ARIA, which can cause lesions in the brain, including edema, swelling, and/or haemorrhages. The FDA mandates intensive ARIA monitoring with repeated MRI brain scans to detect and assess these changes. Until now, identifying and evaluating ARIA has been a labour-intensive process, involving detailed, time-consuming visual comparisons of brain MRI scans by radiologists.
Clinical Validation and Impact
icobrain aria is a deep-learning-based AI solution trained on thousands of brain MRI scans to accurately detect, diagnose, and monitor ARIA and its severity. According to Prof. Jeffrey Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, AI significantly improved radiologists’ ability to detect and classify ARIA, boosting both diagnostic sensitivity and accuracy. Dr. Dirk Smeets, CTO of icometrix, noted that the FDA holds devices in this category to exceptionally high standards of evidence and performance, and this approval reflects the strong evidence behind icobrain aria’s ability to help radiologists assess important safety events.
Broadening Access to Safer Alzheimer's Therapies
George Vradenburg, chairman of UsAgainstAlzheimer's, emphasized that the FDA clearance of icobrain aria makes Alzheimer’s therapies more accessible and safer for patients by providing clinicians with the tools needed to make informed, effective treatment decisions. With icobrain aria, physicians now have a powerful tool that helps them make informed treatment decisions, ensuring that patients receive the right care at the right time.
