The new and only available therapies for Alzheimer’s disease have been linked to the development of specific brain abnormalities known as Amyloid-Related Imaging Abnormalities (ARIA), which can lead to severe neurological complications.
Although ARIA can be detected through brain MRI scans, the assessment process is highly challenging, time-consuming, and complex for radiologists.
icobrain aria, the first ARIA monitoring solution to gain market approval:
icometrix, the leading imaging artificial intelligence (AI) company in the field of neurology, has developed unique AI-based algorithms named icobrain aria. These algorithms are designed to detect and measure ARIA on brain MRI scans. As a result, icobrain aria provides relevant ARIA measures and a severity assessment for both subtypes: ARIA-E and ARIA-H.
icobrain aria has been validated through a unique study, demonstrating significant benefits for radiologists. It enhances radiological reading performance, reduces reading time compared to unassisted ARIA assessments, improves inter-reader agreement for both ARIA-E and ARIA-H severity, and increases diagnostic accuracy, These advantages benefit both general and specialized radiologists.
icobrain aria has now gained market approval in several key regions, such as Europe, Israel, Japan, Switzerland, Turkey, and the United Kingdom.
Prof. Sebastiaan Engelborghs, chair and professor of neurology at the Vrije Universiteit Brussel (VUB, Belgium) and its academic hospital (Universitair Ziekenhuis Brussel): “This market approval for icobrain aria is a game-changer and is well timed”, says Prof. Engelborghs. “We notice an increasing adoption of the amyloid-targeting therapies in the countries where they have market approval. Having access to a solution such as icobrain aria will only increase the confidence of physicians to prescribe these new treatments in a safe way.”, he concludes.
Prof. Ana Franceschi, Northwell Health New York (United States of America) “Digital health technologies, and in particular computer-aided detection of ARIA, AI-related MRI brain quantification, and (semi)quantitative PET analyses have the potential to serve as invaluable tools in clinical practice, particularly by assisting novice readers and trainees, thereby building reader confidence.”
The need for ARIA assessment when treating people with Alzheimer’s disease
Today, 32 million people globally are diagnosed with Alzheimer’s disease, and more than 400 million people are on the Alzheimer’s disease continuum1. These numbers are expected to double every two decades, placing an increasing burden on families, healthcare systems, and society at large. This alarming trend underscores the urgent need to prioritize brain health on the global agenda2,3.
In 2021, a significant milestone was reached with the approval of aducanumab in the US, marking the first available treatment for Alzheimer’s disease. Currently, three amyloid beta-targeting monoclonal antibody therapies—aducanumab, lecanemab, and donanemab—are approved for treating Alzheimer’s disease in the US. In Japan, lecanemab has been approved, with promising developments for donanemab. Meanwhile, in Israel, both aducanumab and lecanemab have received approval.
These pioneering therapies have shown a meaningful impact on amyloid deposits and altering the clinical course of the disease4,5. “However, clinical trials have shown that these treatments can be associated with amyloid-related imaging abnormalities (ARIA)”, says Prof Engelborghs, chair and professor of neurology at the Vrije Universiteit Brussel (VUB, Belgium) and its academic hospital (Universitair Ziekenhuis Brussel).
To mitigate the risk of ARIA and its potentially severe neurological complications, regulators have mandated at least 3 brain MRI scans during the first year of treatment to detect and to mitigate the risk of ARIA and its potentially severe neurological complications, regulators have mandated at least 3 brain MRI scans during the first year of treatment to detect and monitor ARIA. However, the detection and severity assessment of ARIA is a complex, time-consuming process that requires detailed analysis and quantification of:
· Cerebral edema on FLAIR scans (ARIA-E), measuring the longest axis of the edema and counting the number of sites with edema and sulcal infusion involvement.
· Microhemorrhages on T2* scans (ARIA-H), including counting new microhemorrhages.
· Superficial siderosis on T2* scans (ARIA-H), including counting new areas of superficial siderosis.
Figure 1: Examples of several pathologies associated with ARIA
icobrain aria, the first ARIA management solution to gain market approval:
Developed by icometrix, the leading imaging AI company in the field of neurology, icobrain aria provides the automated detection and quantification of both ARIA-E (edema/sulcal effusion) and ARIA-H (hemorrhage/superficial siderosis). The software not only identifies clinically relevant ARIA markers, but also calculates a severity score, aiding radiologists and neurologists in assessing ARIA and safely prescribing anti-amyloid treatments.
Figure 2: Example of icobrain aria report outputs, showing ARIA-E (left) and ARIA-H (right). These reports are used by radiologists in conjunction with annotated brain images.
icobrain aria was developed based on large data sets for individuals on amyloid-targeting therapies, including ARIA cases and ARIA-free cases. It underwent rigorous validation through a large clinical validation study that involved 16 radiologists and over 400 brain MRI scans. The results of this study, published in JAMA Network Open6, demonstrated that the use of icobrain aria:
· Shortened the reading time compared to unassisted ARIA reading
· Increased inter-reader radiological agreement for both ARIA-E and ARIA-H severity
· Enhanced diagnostic performance, benefiting both general and specialized radiologists
Figure 3: This figure presents an example of an ARIA-E case from the clinical validation study 6 that was detected by icobrain aria and confirmed as ARIA-E by all radiologists using the software. Without icobrain aria, 31% of radiologists missed this ARIA-E finding.
With the market approval of icobrain aria in key regions such as Europe, Switzerland, Turkey, Israel, the United Kingdom and Japan, we can now better ensure the safe and effective treatment of Alzheimer’s disease and support the continued global rollout of these treatments. This milestone is vital for patients and families worldwide, as it not only makes treatments more accessible but also ensures careful monitoring, reducing risks and improving outcomes for those living with Alzheimer’s.
“This market approval for icobrain aria is a game-changer and comes at the right time”, says Prof. Engelborghs. “We notice an increasing adoption of the amyloid-targeting therapies in the countries where they have market approval. Having access to a solution such as icobrain aria will only increase the confidence of physicians to prescribe these new treatments in a safe way.”, he concludes. Prof. Ana Franceschi from Northwell Health New York (USA) added, “Digital health technologies, and in particular computer-aided detection of ARIA, AI-related MRI brain quantification, and (semi)quantitative PET analyses have the potential to serve as invaluable tools in clinical practice, particularly by assisting novice readers and trainees, thereby building reader confidence.”
About icometrix
icometrix (Leuven, Belgium; Chicago, USA) is the global leader in AI software solutions that extract clinically meaningful data from brain MRI and CT scans for conditions such as Alzheimer’s Disease, Multiple Sclerosis, Traumatic Brain Injury, Epilepsy, Stroke, Parkinson’s disease, and brain tumors. Their fully automated icobrain software is FDA-approved in the US and holds market approvals across Europe, Japan, Canada, South America, and Australia. With its software now in use at over 100 hospitals worldwide, icometrix collaborates with the largest pharmaceutical and health tech companies. In January 2024, icometrix achieved a significant milestone by securing a CPT reimbursement code for its icobrain software in the US market, further solidifying its leadership in the field, backed by years of scientific evidence demonstrating its clinical value.
References
1. Anders Gustavsson, et al., Global estimates on the number of persons across the Alzheimer’s disease continuum. 2023, doi: 10.1002/alz.12694.
2. Emma Nichols, et al., Global, regional, and national burden of Alzheimer’s disease and other dementias, 1990–2016: a systematic analysis for the Global Burden of Disease Study. 2016, https://doi.org/10.1016/S1474-4422(18)30403-4
3. Harris A. Eyre, Frédéric Destrebecq, Stephanie Kramer, Call to Action: Putting Brain Health on the Global Agenda. 2023, https://www.bakerinstitute.org/research/call-action-putting-brain-health-global-agenda
4. Christopher H. van Dyck et al. Lecanemab in Early Alzheimer’s Disease. 2023, https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
5. John R. Sims et al. Donanemab in Early Symptomatic Alzheimer Disease. 2023, https://jamanetwork.com/journals/jama/article-abstract/2807533
6. Sima, Diana M., et al. “Artificial Intelligence Assistive Software Tool for Automated Detection and Quantification of Amyloid-Related Imaging Abnormalities.” JAMA Network Open 7.2 (2024): e2355800-e2355800.
