{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T17:38:16Z","timestamp":1793295496561,"version":"4.5.0"},"reference-count":22,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi231638-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Amyloid-related imaging abnormalities (ARIA) are brain magnetic resonance imaging (MRI) findings associated with the use of amyloid-\u03b2\u2013directed monoclonal antibody therapies in Alzheimer disease (AD). ARIA monitoring is important to inform treatment dosing decisions and might be improved through assistive software.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the clinical performance of an artificial intelligence (AI)\u2013based software tool for assisting radiological interpretation of brain MRI scans in patients monitored for ARIA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>This diagnostic study used a multiple-reader multiple-case design to evaluate the diagnostic performance of radiologists assisted by the software vs unassisted. The study enrolled 16 US Board of Radiology\u2013certified radiologists to perform radiological reading with (assisted) and without the software (unassisted). The study encompassed 199 retrospective cases, where each case consisted of a predosing baseline and a postdosing follow-up MRI of patients from aducanumab clinical trials PRIME, EMERGE, and ENGAGE. Statistical analysis was performed from April to July 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-7\">\n                    <jats:title>Exposures<\/jats:title>\n                    <jats:p>Use of icobrain aria, an AI-based assistive software for ARIA detection and quantification.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>Coprimary end points were the difference in diagnostic accuracy between assisted and unassisted detection of ARIA-E (edema and\/or sulcal effusion) and ARIA-H (microhemorrhage and\/or superficial siderosis) independently, assessed with the area under the receiver operating characteristic curve (AUC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among the 199 participants included in this study of radiological reading performance, mean (SD) age was 70.4 (7.2) years; 105 (52.8%) were female; 23 (11.6%) were Asian, 1 (0.5%) was Black, 157 (78.9%) were White, and 18 (9.0%) were other or unreported race and ethnicity. Among the 16 radiological readers included, 2 were specialized neuroradiologists (12.5%), 11 were male individuals (68.8%), 7 were individuals working in academic hospitals (43.8%), and they had a mean (SD) of 9.5 (5.1) years of experience. Radiologists assisted by the software were significantly superior in detecting ARIA than unassisted radiologists, with a mean assisted AUC of 0.87 (95% CI, 0.84-0.91) for ARIA-E detection (AUC improvement of 0.05 [95% CI, 0.02-0.08];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.001]) and 0.83 (95% CI, 0.78-0.87) for ARIA-H detection (AUC improvement of 0.04 [95% CI, 0.02-0.07];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.001). Sensitivity was significantly higher in assisted reading compared with unassisted reading (87% vs 71% for ARIA-E detection; 79% vs 69% for ARIA-H detection), while specificity remained above 80% for the detection of both ARIA types.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi231638-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>This diagnostic study found that radiological reading performance for ARIA detection and diagnosis was significantly better when using the AI-based assistive software. Hence, the software has the potential to be a clinically important tool to improve safety monitoring and management of patients with AD treated with amyloid-\u03b2\u2013directed monoclonal antibody therapies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2023.55800","type":"journal-article","created":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T11:01:16Z","timestamp":1707735676000},"page":"e2355800","source":"Crossref","is-referenced-by-count":44,"title":["Artificial Intelligence Assistive Software Tool for Automated Detection and Quantification of Amyloid-Related Imaging Abnormalities"],"prefix":"10.1001","volume":"7","author":[{"given":"Diana M.","family":"Sima","sequence":"first","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thanh V\u00e2n","family":"Phan","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Van Eyndhoven","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Vercruyssen","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Magalh\u00e3es","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arno","family":"Liseune","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arne","family":"Brys","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Frenyo","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasilis","family":"Terzopoulos","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celine","family":"Maes","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Guo","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Hughes","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Refaat E.","family":"Gabr","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Willem","family":"Huijbers","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paramita","family":"Saha-Chaudhuri","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gioacchino G.","family":"Curiale","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Becker","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shibeshih","family":"Belachew","sequence":"additional","affiliation":[{"name":"Biogen Digital Health, Biogen, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim","family":"Van Hecke","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annemie","family":"Ribbens","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Smeets","sequence":"additional","affiliation":[{"name":"icometrix, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2024,2,12]]},"reference":[{"issue":"4","key":"zoi231638r1","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1016\/j.jalz.2011.05.2351","article-title":"Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer\u2019s Association Research Roundtable Workgroup.","volume":"7","author":"Sperling","year":"2011","journal-title":"Alzheimers Dement"},{"issue":"1","key":"zoi231638r2","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1001\/jamaneurol.2021.4161","article-title":"Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease.","volume":"79","author":"Salloway","year":"2022","journal-title":"JAMA Neurol"},{"issue":"1","key":"zoi231638r3","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1056\/NEJMoa2212948","article-title":"Lecanemab in early Alzheimer\u2019s disease.","volume":"388","author":"van Dyck","year":"2023","journal-title":"N Engl J Med"},{"issue":"18","key":"zoi231638r4","doi-asserted-by":"publisher","first-page":"1691","DOI":"10.1056\/NEJMoa2100708","article-title":"Donanemab in early Alzheimer\u2019s disease.","volume":"384","author":"Mintun","year":"2021","journal-title":"N Engl J Med"},{"issue":"2","key":"zoi231638r5","doi-asserted-by":"publisher","first-page":"221","DOI":"10.14283\/jpad.2022.34","article-title":"Aducanumab: appropriate use recommendations update.","volume":"9","author":"Cummings","year":"2022","journal-title":"J Prev Alzheimers Dis"},{"issue":"3","key":"zoi231638r6","doi-asserted-by":"publisher","first-page":"362","DOI":"10.14283\/jpad.2023.30","article-title":"Lecanemab: appropriate use recommendations.","volume":"10","author":"Cummings","year":"2023","journal-title":"J Prev Alzheimers Dis"},{"issue":"2","key":"zoi231638r7","doi-asserted-by":"publisher","first-page":"211","DOI":"10.14283\/jpad.2022.21","article-title":"Detection and management of amyloid-related imaging abnormalities in patients with Alzheimer\u2019s disease treated with anti-amyloid beta therapy.","volume":"9","author":"Barakos","year":"2022","journal-title":"J Prev Alzheimers Dis"},{"issue":"3","key":"zoi231638r8","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1001\/jamaneurol.2021.5205","article-title":"Amyloid-related imaging abnormalities and \u00df-amyloid-targeting antibodies: a systematic review.","volume":"79","author":"Filippi","year":"2022","journal-title":"JAMA Neurol"},{"issue":"7","key":"zoi231638r9","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1016\/j.jalz.2017.06.114","article-title":"Validation of a simple severity scale for assessing ARIA-E.","volume":"13","author":"Bracoud","year":"2017","journal-title":"Alzheimers Dement"},{"issue":"9","key":"zoi231638r10","doi-asserted-by":"publisher","first-page":"E19","DOI":"10.3174\/ajnr.A7586","article-title":"Amyloid-related imaging abnormalities with emerging Alzheimer disease therapeutics: detection and reporting recommendations for clinical practice.","volume":"43","author":"Cogswell","year":"2022","journal-title":"AJNR Am J Neuroradiol"},{"issue":"3","key":"zoi231638r11","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1016\/S1474-4422(12)70015-7","article-title":"Amyloid-related imaging abnormalities in patients with Alzheimer\u2019s disease treated with bapineuzumab: a retrospective analysis.","volume":"11","author":"Sperling","year":"2012","journal-title":"Lancet Neurol"},{"issue":"10","key":"zoi231638r12","doi-asserted-by":"publisher","first-page":"1958","DOI":"10.3174\/ajnr.A3500","article-title":"MR imaging features of amyloid-related imaging abnormalities.","volume":"34","author":"Barakos","year":"2013","journal-title":"AJNR Am J Neuroradiol"},{"issue":"2","key":"zoi231638r13","doi-asserted-by":"publisher","first-page":"557","DOI":"10.3233\/JAD-160216","article-title":"Central review of amyloid-related imaging abnormalities in two phase III clinical trials of bapineuzumab in mild-to-moderate Alzheimer\u2019s disease patients.","volume":"57","author":"Ketter","year":"2017","journal-title":"J Alzheimers Dis"},{"issue":"11","key":"zoi231638r15","doi-asserted-by":"publisher","first-page":"4414","DOI":"10.1093\/brain\/awad188","article-title":"Amyloid-related imaging abnormalities (ARIA): radiological, biological and clinical characteristics.","volume":"146","author":"Hampel","year":"2023","journal-title":"Brain"},{"issue":"1","key":"zoi231638r18","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1080\/10543406.2017.1378668","article-title":"Design, data monitoring, and analysis of clinical trials with co-primary endpoints: a review.","volume":"28","author":"Hamasaki","year":"2018","journal-title":"J Biopharm Stat"},{"issue":"3","key":"zoi231638r19","doi-asserted-by":"publisher","first-page":"353","DOI":"10.1016\/j.acra.2005.11.030","article-title":"One-shot estimate of MRMC variance: AUC.","volume":"13","author":"Gallas","year":"2006","journal-title":"Acad Radiol"},{"issue":"15","key":"zoi231638r20","doi-asserted-by":"publisher","first-page":"2586","DOI":"10.1080\/03610920802610084","article-title":"A framework for random-effects ROC analysis: biases with the bootstrap and other variance estimators.","volume":"38","author":"Gallas","year":"2009","journal-title":"Commun Stat A-Theor"},{"key":"zoi231638r14","author":"Gutt","year":"2019"},{"key":"zoi231638r16","author":"Ourselin","year":"2001"},{"key":"zoi231638r17","author":"\u00c7i\u00e7ek","year":"2016"},{"key":"zoi231638r21","unstructured":"Gallas? BD. iMRMC-java v4.0.0: Application for analyzing and sizing MRMC reader studies. 2017. Accessed January 8, 2024. https:\/\/github.com\/DIDSR\/iMRMC\/releases"},{"key":"zoi231638r22","unstructured":"US Food and Drug Administration. iMRMC: software to do multi-reader multi-case statistical analysis of reader studies. Accessed January 8, 2024. https:\/\/www.fda.gov\/medical-devices\/science-and-research-medical-devices\/imrmc-software-do-multi-reader-multi-case-statistical-analysis-reader-studies"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2814923\/sima_2024_oi_231638_1707168792.97267.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T11:01:20Z","timestamp":1707735680000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2814923"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,12]]},"references-count":22,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2,5]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2023.55800","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,12]]}}}