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Dementia"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>Cross\u2010cohort validation studies for plasma phosphorylated tau (p\u2010tau) 217 are limited. We evaluated the Janssen plasma p\u2010tau217+ assay and proposed a cutpoint value in three independent community\u2010based cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>We included n\u00a0=\u00a0441 participants (age\u00a0=\u00a070.3\u00a0\u00b1\u00a07.3) from three independent community\u2010based cohorts with amyloid\u2010beta\u2013positron emission tomography (A\u03b2\u2010PET), tau\u2010PET, clinical, and cognitive information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The cohorts had low pre\u2010test probability (%A\u03b2 positivity\u00a0=\u00a014.9\u201324.7) and were predominantly cognitively normal (&gt;\u00a073%). Plasma p\u2010tau217+ had high accuracy for abnormal A\u03b2 PET (areas under the curve [AUCs]\u00a0=\u00a081\u201086%), good correlation with A\u03b2\u2010PET burden (0.336\u20100.397) that was highest in the cohort with the most A\u03b2\u2010PET\u2010positive participants, and the biomarker concentrations were highest in the joint A\u03b2\u2010PET and tau\u2010PET positive group. Negative predictive value (NPV) was high across cohorts (\u226493%) but positive predictive value (PPV) was consistently poor (&lt;\u00a057%). Sensitivity and specificity averaged 75% and 84%, respectively. A combined cohort cutpoint of 0.05pg\/ml gave AUC\u00a0=\u00a084.5%, NPV\u00a0=\u00a094%, PPV\u00a0=\u00a050%, sensitivity\u00a0=\u00a075%, and specificity\u00a0=\u00a084%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>Plasma p\u2010tau217+ can rule out A\u03b2 pathophysiology due to Alzheimer's disease at the population level. Cohort\u2010level %A\u03b2\u2010PET positivity influences accuracies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlights<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>Plasma phosphorylated tau (p\u2010tau) 217 assays have demonstrated potential to identify older adults with brain amyloid pathology due to Alzheimer's disease.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Community\u2010based studies are crucial for accessing the clinical validity of fluid biomarkers and their real\u2010world applicability.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>We evaluated the Janssen plasma p\u2010tau217+ assay in three community\u2010based cohorts.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Janssen plasma p\u2010tau217+ identified amyloid\u2010beta abnormalities across three diverse cohorts of community\u2010dwelling older adults.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>High NPV indicates p\u2010tau217+ as a good tool for initial screening to enrich for high\u2010risk individuals particularly for cohort studies and clinical trial participation.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/alz.70916","type":"journal-article","created":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T10:31:03Z","timestamp":1763807463000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Cross\u2010cohort validation and cutpoint estimation of the Janssen plasma p\u2010tau217+ assay in predominantly cognitively normal community studies"],"prefix":"10.1002","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1422-8562","authenticated-orcid":false,"given":"Wasiu G.","family":"Balogun","sequence":"first","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Biofluid Biomarker Laboratory Western Psychiatric Hospital, University of Pittsburgh Medical Center  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuemei","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Biofluid Biomarker Laboratory Western Psychiatric Hospital, University of Pittsburgh Medical Center  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gallen","family":"Triana\u2010Baltzer","sequence":"additional","affiliation":[{"name":"Neuroscience Biomarkers Johnson &amp; Johnson La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anum","family":"Saeed","sequence":"additional","affiliation":[{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Heart and Vascular Institute Department of Medicine University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Happiness E.","family":"Aigbogun","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Biofluid Biomarker Laboratory Western Psychiatric Hospital, University of Pittsburgh Medical Center  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Gogola","sequence":"additional","affiliation":[{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Radiology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian J.","family":"Lopresti","sequence":"additional","affiliation":[{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Radiology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor L","family":"Villemagne","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Ganguli","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Radiology University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Epidemiology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hartmuth","family":"Kolb","sequence":"additional","affiliation":[{"name":"Neuroscience Biomarkers Johnson &amp; Johnson La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth E.","family":"Snitz","sequence":"additional","affiliation":[{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Neurology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oscar L.","family":"Lopez","sequence":"additional","affiliation":[{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Department of Neurology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann D.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven E.","family":"Reis","sequence":"additional","affiliation":[{"name":"Department of Cardiology University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1422-4358","authenticated-orcid":false,"given":"Thomas K.","family":"Karikari","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Alzheimer's Disease Research Center University of Pittsburgh  Pittsburgh Pennsylvania USA"},{"name":"Biofluid Biomarker Laboratory Western Psychiatric Hospital, University of Pittsburgh Medical Center  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587-023-00403-3"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13026"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-02869-z"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.64.3.noc60123"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212948"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587-023-00400-6"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-022-01005-8"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/YCO.0000000000000851"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13859"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.12134"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-01822-2"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.5319"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awac333"},{"key":"e_1_2_8_15_1","first-page":"1","article-title":"Plasma p217+tau versus NAV4694 amyloid and MK6240 tau PET across the Alzheimer's continuum","volume":"14","author":"Dor\u00e9 V","year":"2022","journal-title":"Alzheimers Dement Diagn Assess Dis Monit"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2024.105046"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43856\u2010025\u201000768\u2010z"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11682-020-00334-2"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13024-024-00753-5"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/JGP.0b013e3181cdee4f"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnagi.2021.669490"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2013.02.007"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.2967\/jnumed.123.265941"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awae346"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.4485"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-03400-0"}],"container-title":["Alzheimer's &amp; 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