A novel ultrasensitive assay for plasma p-tau217: Performance in individuals with subjective cognitive decline and early Alzheimer's disease

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• dc.contributor.author González Ortiz, Fernando
• dc.contributor.author González Escalante, Armand
• dc.contributor.author Ortiz Romero, Paula, 1994-
• dc.contributor.author Minguillón, Carolina
• dc.contributor.author Contador, Jose
• dc.contributor.author Suárez-Calvet, Marc
• dc.contributor.author Blennow, Kaj
• dc.date.accessioned 2024-09-27T06:20:42Z
• dc.date.available 2024-09-27T06:20:42Z
• dc.date.issued 2024
• dc.description.abstract Introduction: Detection of Alzheimer's disease (AD) pathophysiology among individuals with mild cognitive changes and those experiencing subjective cognitive decline (SCD) remains challenging. Plasma phosphorylated tau 217 (p-tau217) is one of the most promising of the emerging biomarkers for AD. However, accessible methods are limited. Methods: We employed a novel p-tau217 immunoassay (University of Gothenburg [UGOT] p-tau217) in four independent cohorts (n = 308) including a cerebrospinal fluid (CSF) biomarker-classified cohort (Discovery), two cohorts consisting mostly of cognitively unimpaired (CU) and mild cognitively impaired (MCI) participants (MYHAT and Pittsburgh), and a population-based cohort of individuals with SCD (Barcelonaβeta Brain Research Center's Alzheimer's At-Risk Cohort [β-AARC]). Results: UGOT p-tau217 showed high accuracy (area under the curve [AUC] = 0.80-0.91) identifying amyloid beta (Aβ) pathology, determined either by Aβ positron emission tomography or CSF Aβ42/40 ratio. In individuals experiencing SCD, UGOT p-tau217 showed high accuracy identifying those with a positive CSF Aβ42/40 ratio (AUC = 0.91). Discussion: UGOT p-tau217 can be an easily accessible and efficient way to screen and monitor patients with suspected AD pathophysiology, even in the early stages of the continuum.
• dc.description.sponsorship This publication is part of the BBRC's β-AARC study, the MYHAT study, and the Pittsburgh study. The authors would like to express their most sincere gratitude to the project participants, without whom this research would have not been possible. The authors would like to thank Altoida for kindly supporting the CSF AD core biomarker characterisation of β-AARC study participants. F.G.-O. was funded by the Anna Lisa and Brother Björnsson's Foundation and Emil och Maria Palms Foundation. H.Z. is a Wallenberg Scholar supported by grants from the Swedish Research Council (#2022-01018 and #2019-02397), the European Union's Horizon Europe research and innovation ə under grant agreement No 101053962, Swedish State Support for Clinical Research (#ALFGBG-71320), the Alzheimer Drug Discovery Foundation (ADDF), USA (#201809-2016862), the AD Strategic Fund and the Alzheimer's Association (#ADSF-21-831376-C, #ADSF-21-831381-C, and #ADSF-21-831377-C), the Bluefield Project, the Olav Thon Foundation, the Erling-Persson Family Foundation, Stiftelsen för Gamla Tjänarinnor, Hjärnfonden, Sweden (#FO2022-0270), the European Union's Horizon 2020 research and innovation ə under the Marie Skłodowska-Curie grant agreement No 860197 (MIRIADE), the European Union Joint Programme – Neurodegenerative Disease Research (JPND2021-00694), the National Institute for Health and Care Research University College London Hospitals Biomedical Research Centre, and the UK Dementia Research Institute at UCL (UKDRI-1003). K.B. is supported by the Swedish Research Council (#2017-00915 and #2022-00732), the Swedish Alzheimer Foundation (#AF-930351, #AF-939721 and #AF-968270), Hjärnfonden, Sweden (#FO2017-0243 and #ALZ2022-0006), the Swedish state under the agreement between the Swedish government and the County Councils, the ALF-agreement (#ALFGBG-715986 and #ALFGBG-965240), the Alzheimer's Association 2021 Zenith Award (ZEN-21-848495), and the Alzheimer's Association 2022-2025 Grant (SG-23-1038904 QC). M.S.C. receives funding from the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme (Grant agreement No. 948677), Project “PI19/00155”, funded by Instituto de Salud Carlos III (ISCIII) and co-funded by the European Union, and from a fellowship from “la Caixa” Foundation (ID 100010434) and from the European Union's Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 847648 (LCF/BQ/PR21/11840004). T.K.K. was supported by grants 1 R01 AG083874-01 and 1U24AG082930 from the National Institutes of Health (NIH), the Swedish Research Council (Vetenskåpradet; 2021-03244), the Alzheimer's Association (AARF-21-850325), the Swedish Alzheimer Foundation (Alzheimerfonden), the Aina (Ann) Wallströms and Mary-Ann Sjöbloms Stiftelsen, and the Emil och Wera Cornells stiftelsen. M.G. and the MYHAT study were funded by the NIH (grants AG052521 and R37 AG023651). The other Pittsburgh cohorts were financed by the NIH (grants P30 AG066468, P01AG025204, RF1AG025516, RF1AG052525, R01AG052446, and R01AG052446).
• dc.format.mimetype application/pdf
• dc.identifier.citation Gonzalez-Ortiz F, Ferreira PCL, González-Escalante A, Montoliu-Gaya L, Ortiz-Romero P, Kac PR, et al. A novel ultrasensitive assay for plasma p-tau217: Performance in individuals with subjective cognitive decline and early Alzheimer's disease. Alzheimers Dement. 2024 Feb;20(2):1239-49. DOI: 10.1002/alz.13525
• dc.identifier.doi http://dx.doi.org/10.1002/alz.13525
• dc.identifier.issn 1552-5260
• dc.identifier.uri http://hdl.handle.net/10230/61248
• dc.language.iso eng
• dc.publisher Elsevier
• dc.relation.ispartof Alzheimers Dement. 2024 Feb;20(2):1239-49
• dc.relation.projectID info:eu-repo/grantAgreement/EC/HE/101053962
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/860197
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/948677
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/847648
• dc.rights © 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword Alzheimer's disease
• dc.subject.keyword Blood biomarkers
• dc.subject.keyword Early diagnosis
• dc.subject.keyword p-tau217
• dc.subject.keyword Preclinical
• dc.subject.keyword Subjective cognitive decline
• dc.title A novel ultrasensitive assay for plasma p-tau217: Performance in individuals with subjective cognitive decline and early Alzheimer's disease
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion