icobrain aria: a breakthrough in Alzheimer’s disease management and care
A new era in the management of patients with Alzheimer’s disease
Today, 32 million people are suffering from Alzheimer’s disease globally, and it is reported that more than 400 million people are on the Alzheimer’s disease continuum (1). As these numbers are expected to double every two decades, increasingly impacting families, healthcare systems, and the wider society, there is a strong call to action to put brain health on the global agenda (2,3).
During the last decades, many pharmaceutical companies have been investing heavily in the development of disease-modifying therapies (DMTs) for Alzheimer’s disease (4). The first amyloid beta targeting monoclonal antibody therapies have demonstrated a meaningful impact on the deposition of amyloid and the clinical course of the disease (5,6). However, clinical trials have shown that these therapies can be associated with amyloid-related imaging abnormalities (ARIA). Although findings may on some occasions be mild and asymptomatic, ARIA can be symptomatic, and is on rare occasions associated with life-threatening events. Hence, ARIA safety monitoring through regular brain Magnetic Resonance Imaging (MRI) scans will play an important role in the follow-up of patients treated with amyloid beta-directed monoclonal antibodies.
The need for computer-aided diagnosis solutions to support ARIA assessment
The need for regular ARIA monitoring was emphasized by the FDA, mandating at least 3 follow-up brain MRI scans in addition to the baseline pre-treatment MRI in the label of both Aduhelm and Leqembi (7,8). Given the large number of people who could be eligible for the new DMTs, these ARIA monitoring brain MRI requests will impact the radiology workload significantly. Furthermore, ARIA detection and severity assessment is a challenging and time-consuming task. Indeed, ARIA (especially at the earliest stage of ‘mild’ radiological severity) can be very subtle and involves a detailed analysis and detection/quantification of cerebral edema (ARIA-E), microhemorrhages, and superficial siderosis (ARIA-H) on brain MRI FLAIR and T2* scans.
Some clear cases of ARIA presentations are shown in the Figure below (9,10).
The term ARIA was introduced in 2010 to encompass the spectrum of MRI findings observed in patients receiving investigational anti–amyloid therapies for AD. Given this specific link to these therapies, real-world experience and education is very limited. In this context, it was reported that up to 84% of ARIA cases can be missed by local radiologists (11). This was also highlighted in the recent review paper on ARIA by Hampel et al. (2023), suggesting the need for a quantitative computer-aided diagnosis tool that can support radiological ARIA assessment (12).
Introducing icobrain aria
During the last two years, the icometrix team has been applying their state-of-the-art AI expertise in lesion detection, their unique experience in longitudinal brain MRI follow-up assessment, and their regulatory skills to develop icobrain aria (FDA pending). icobrain aria is developed based on large data sets of individuals on amyloid-targeting therapies, including ARIA cases and ARIA-free cases. The AI-based brain MRI solution allows for the automated detection and quantification of both ARIA-E (edema/sulcal effusion) and ARIA-H (hemorrhage/superficial siderosis). Using a unique longitudinal neural network, the baseline MRI is compared with the post-dosing follow-up MRI scan, assisting radiologists and clinicians with an extra pair of eyes (or AIs), allowing for robust, consistent, and standardized safety monitoring. Similar to the existing portfolio of icobrain solutions, color-coded image annotations and a quantitative summary report are seamlessly integrated into the hospital workflow and contain the following information:
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An example of the icobrain aria reports for ARIA-E and ARIA-H is provided below.
icobrain aria: rigorously examined for its clinical validity
This week, at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in Boston, we are presenting the first results of a first-of-its-kind reader study that evaluates the clinical validity of icobrain aria. A multi-case, multi-reader (MRMC) study was performed, including 16 (ARIA-reading trained) radiologists and 398 MRI scans, which were read with and without the assistance of icobrain aria. Results were compared with a ground truth, which is defined by the consensus reading of three leading global ARIA experts.
A significant improvement in radiological ARIA-E and ARIA-H detection and severity assessment was shown when icobrain aria was used, as summarized in the Table below (13). The significant impact of the software on the radiological reading is further confirmed by the high Cohen’s d effect sizes of 2.0 for ARIA-H and 2.5 for ARIA-E. These results strongly indicate that icobrain aria significantly improves the safety monitoring and management of AD patients treated with amyloid beta-directed monoclonal antibodies.
Impacting Alzheimer's disease management and care
We are incredibly excited to discuss the icobrain aria results at the CTAD2023 conference this week (see the poster below). The introduction of disease-modifying therapies is opening a new era for the management and care of Alzheimer’s disease, and solutions such as icobrain aria will be crucial to optimize benefits and risks in each individual. We can’t wait to integrate this solution, together with the broader icobrain portfolio, in hospital systems worldwide. Very soon, we will announce several further solutions that will impact the care of Alzheimer’s, stay tuned!
References
Thrilled about AI's role in transforming Alzheimer's care! Its potential in diagnosis and treatment is a game-changer. Eager to see its impact on healthcare, particularly for underprivileged communities.
Major Kudos! Excellent example of precision diagnostics and disease management made possible by leveraging development of AI and collaboration techniques. (20 years ago as a student learning and applying geometric modelling, I worked on a project which fit surfaces on MRI data to identify patterns for diseases. Seeing this progress is just great!)
Marketing & Events Specialist @ Verhaert Masters in Innovation
1yProficiat!!!!!
Impacting translational success with AI
1yMajor kudos to the icometrix team! Congratulations on this important milestone, not just for the care of patients using anti-amyloid therapies but for the role of AI in augmenting the work of radiologists and clinicians. We have had safety and efficacy Pharmacogenomic (PGx) biomarkers for many years, and I would argue that with icobrain aria we have the first example of a safety "pharmaco-imaging biomarker" - Precision Neurology is becoming a reality!
Alzheimer's and Related Disorders
1yAnd applications of this approach bound to grow in time. Congratulations!