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Current methods, including positron emission tomography (PET) and cerebrospinal fluid (CSF) analysis, are costly and invasive methods that may limit access to new treatments. Plasma tau phosphorylated at threonine-217 (P-tau217) presents a promising alternative, yet optimal cutoffs for treatment eligibility with DMTs like aducanumab require further investigation. This study evaluates the efficacy of one- and two-cutoff strategies for determining DMT eligibility at the Butler Hospital Memory &amp; Aging Program (MAP).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this retrospective, cross-sectional diagnostic cohort study, we first developed P-tau217 cutoffs using site-specific and BioFINDER-2\u00a0training data, which were then tested in potential DMT candidates from Butler MAP (total n\u2009=\u2009150). ROC analysis was used to calculate the area under the curve (AUC) and accuracy of P-tau217 interpretation strategies, using A\u03b2-PET\/CSF testing as the standard of truth.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Potential DMT candidates at Butler MAP (n\u2009=\u200950), primarily diagnosed with mild cognitive impairment (n\u2009=\u200929 [58%]) or mild dementia (21 [42%]), were predominantly A\u03b2-positive (38 [76%]), and half (25 [50%]) were subsequently treated with aducanumab. Elevated P-tau217 predicted cerebral A\u03b2 positivity in potential DMT candidates (AUC\u2009=\u20090.97 [0.92\u20131]), with diagnostic accuracy ranging from 0.88 (0.76\u20130.95, <jats:italic>p<\/jats:italic>\u2009=\u20090.028) to 0.96 (0.86\u20131, <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). When using site-specific cutoffs, a subset of DMT candidates (10%) exhibited borderline P-tau217 (between 0.273 and 0.399\u00a0pg\/mL) that would have potentially required confirmatory testing.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study, which included participants treated with aducanumab, confirms the utility of one- and two-cutoff strategies for interpreting plasma P-tau217 in assessing DMT eligibility. Using P-tau217 could potentially replace more invasive diagnostic methods, and all aducanumab-treated participants would have been deemed eligible based on P-tau217. However, false positives remain a concern, particularly when applying externally derived cutoffs that exhibited lower specificity which could have led to inappropriate treatment of A\u03b2-negative participants. Future research should focus on prospective validation of P-tau217 cutoffs to enhance their generalizability and inform standardized treatment decision-making across diverse populations.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13195-024-01521-9","type":"journal-article","created":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T07:01:59Z","timestamp":1720249319000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Clinical application of plasma P-tau217 to assess eligibility for amyloid-lowering immunotherapy in memory clinic patients with early Alzheimer\u2019s disease"],"prefix":"10.1186","volume":"16","author":[{"given":"Matthew D.","family":"Howe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karysa J.","family":"Britton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah E.","family":"Joyce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Menard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheina","family":"Emrani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary J.","family":"Kunicki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie A.","family":"Faust","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brittany C.","family":"Dawson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meghan C.","family":"Riddle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward D.","family":"Huey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shorena","family":"Janelidze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oskar","family":"Hansson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen P.","family":"Salloway","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,7,6]]},"reference":[{"issue":"5","key":"1521_CR1","doi-asserted-by":"publisher","first-page":"506","DOI":"10.1038\/s43587-023-00403-3","volume":"3","author":"O Hansson","year":"2023","unstructured":"Hansson O, Blennow K, Zetterberg H, Dage J. 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Neurol Sci. 2024;45(3):1041\u201350.","DOI":"10.1007\/s10072-023-07076-1"}],"container-title":["Alzheimer's Research &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13195-024-01521-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13195-024-01521-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13195-024-01521-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T07:05:19Z","timestamp":1720249519000},"score":1,"resource":{"primary":{"URL":"https:\/\/alzres.biomedcentral.com\/articles\/10.1186\/s13195-024-01521-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,6]]},"references-count":36,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["1521"],"URL":"https:\/\/doi.org\/10.1186\/s13195-024-01521-9","relation":{},"ISSN":["1758-9193"],"issn-type":[{"value":"1758-9193","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,6]]},"assertion":[{"value":"14 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 July 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All study procedures adhered to the ethical standards of the Butler Hospital Institutional Review Board (IRB #2108\u2013001, #1604\u2013001) and the Helsinki Declaration of 1975. All participants provided written consent to participate in the study, to undergo all study procedures and to publish deidentified data collected as part of study participation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Neither the drug manufacturer (Biogen, Inc.) nor the assay manufacturer (Eli Lilly, Inc.) had any direct role in the design and conduct of the study; in the collection, analysis, and interpretation of data; in the preparation of the manuscript; or in the review or approval of the manuscript.M. Howe: <i>None to disclose.<\/i> K. Britton: <i>None to disclose.<\/i> H. Joyce: <i>None to disclose.<\/i> S. Emrani: <i>None to disclose.<\/i> Z. Kunicki: <i>None to disclose.<\/i> W. Menard: <i>None to disclose.<\/i> M. Faust: <i>None to disclose.<\/i> B. Dawson: <i>None to disclose.<\/i> M. Riddle: <i>Dr. Riddle receives salary support as a site principal investigator for Biogen (EMBARK, ENVISION, CELIA), Eli Lilly (TRAILBLAZER-6), Janssen (AUTONOMY) and Eisai (BAN 2401).<\/i> E. Huey: <i>None to disclose.<\/i> S. Janelidze: <i>None to disclose.<\/i> O. Hansson: <i>Dr. Hansson has acquired research support (for the institution) from ADx, AVID Radiopharmaceuticals, Biogen, Eli Lilly, Eisai, Fujirebio, GE Healthcare, Pfizer, and Roche. In the past 2\u00a0years, he has received consultancy\/speaker fees from AC Immune, Amylyx, Alzpath, BioArctic, Biogen, Bristol Meyer Squibb, Cerveau, Eisai, Eli Lilly, Fujirebio, Merck, Novartis, Novo Nordisk, Roche, Sanofi and Siemens.<\/i> S. Salloway: <i>Dr. Salloway has provided consultation to Biogen, Eisai, Avid, Lilly, Genentech, and Roche; he was a site principal investigator on the PRIME and ENGAGE studies and co-chair of the Investigator Steering Committee for the ENGAGE study. Dr. Salloway is an author on the Appropriate Use Recommendations (AUR) for Aducanumab and Lecanemab. Butler Hospital has received research grants from Biogen, Eisai, Avid, Roche, Genentech, Janssen and Lilly.<\/i>","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"154"}}