AI-based ARIA detection software could bring 'renewed hope' for people undergoing Alzheimer's treatment

A new artificial intelligence-based software that helps streamline the process of identifying and quantifying amyloid-related imaging abnormalities (ARIA) in patients undergoing treatment for Alzheimer’s disease has just been cleared by the U.S. Food and Drug Administration. 

AI-driven software developer icometrix announced the clearance of Icobrain ARIA on Nov. 14. The software is the first of its kind to achieve approval for detecting, measuring and grading ARIA on MRI scans—a task that is critical in managing the treatment of Alzheimer’s. 

"We are thrilled to announce FDA authorization of the first-ever computer-aided detection and diagnosis solution in neuroradiology,” icometrix Chief Technology Officer Dirk Smeets, PhD, said in the announcement. “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 that can impact treatment and patient care." 

The authorization comes after a wave of breakthroughs in Alzheimer’s treatment. Since 2021, three new drugs have all been approved by the FDA. Aduhelm slows the progression of Alzheimer’s, while Leqembi and Kisunla are therapies that target amyloid-related buildup in the brain.

Though effective, these medications can trigger the development of ARIA, which can be deadly if left untreated. The only way to determine whether someone is developing ARIA is through imaging, specifically via MRI. Patients undergoing these treatments require frequent MR imaging to ensure that signs of ARIA are caught before they progress. However, these interpretations can be both time-consuming and inconsistent. 

Deep learning-based icobrain aria was trained on thousands of brain MRI scans. It works in the background of radiologists interpreting brain MRIs and automatically generates ARIA assessment reports. In a large clinical trial, the software was shown to significantly improve the accuracy of radiologists’ ARIA analyses. 

George Vradenburg, chairman of UsAgainstAlzheimer's, recently expressed enthusiam about the new authorization, stating that the software is spreading optimism among those impacted. 

"For families facing Alzheimer's disease, the new disease-modifying therapies have brought renewed hope,” Vradenburg said. “Thanks to the FDA clearance of Icobrain ARIA, Alzheimer's therapies are more accessible and safer for patients, as it provides clinicians with the tools they need to make informed, effective treatment decisions.” 

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