{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T22:59:43Z","timestamp":1791413983061,"version":"4.3.3"},"reference-count":52,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T00:00:00Z","timestamp":1676505600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>We assessed the use of cerebrospinal fluid (CSF) biomarkers as an alternative to positron emission tomography (PET) for brain amyloid beta (A\u03b2) pathology confirmation in the EMERGE and ENGAGE clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>EMERGE and ENGAGE were randomized, placebo\u2010controlled, Phase 3 trials of aducanumab in participants with early Alzheimer's disease. Concordance between CSF biomarkers (A\u03b242, A\u03b240, phosphorylated tau 181, and total tau) and amyloid PET status (visual read) at screening was examined.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Robust concordance between CSF biomarkers and amyloid PET visual status was observed (for A\u03b242\/A\u03b240, AUC: 0.90; 95% CI: 0.83\u20100.97; <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.0001), confirming CSF biomarkers as a reliable alternative to amyloid PET in these studies. Compared with single CSF biomarkers, CSF biomarker ratios showed better agreement with amyloid PET visual reads, demonstrating high diagnostic accuracy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>These analyses add to the growing body of evidence supporting CSF biomarkers as reliable alternatives to amyloid PET imaging for brain A\u03b2 pathology confirmation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Highlights<\/jats:title><jats:p><jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>CSF biomarkers and amyloid PET concordance were assessed in Ph3 aducanumab trials.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Robust concordance between CSF biomarkers and amyloid PET was observed.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>CSF biomarker ratios increased diagnostic accuracy over single CSF biomarkers.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>CSF A\u03b242\/A\u03b240 demonstrated high concordance with amyloid PET.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Results support CSF biomarker testing as a reliable alternative to amyloid PET.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:sec>","DOI":"10.1002\/alz.12919","type":"journal-article","created":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T13:07:06Z","timestamp":1676552826000},"page":"3379-3388","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["CSF biomarker concordance with amyloid PET in Phase 3 studies of aducanumab"],"prefix":"10.1002","volume":"19","author":[{"given":"Laura","family":"Nisenbaum","sequence":"first","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Martone","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianle","family":"Chen","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajasimhan","family":"Rajagovindan","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gersham","family":"Dent","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Beaver","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1371-2536","authenticated-orcid":false,"given":"Carrie","family":"Rubel","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annie","family":"Racine","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping","family":"He","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Harrison","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Dean","sequence":"additional","affiliation":[{"name":"Robert A. 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