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| Pàgina inicial > Articles > Articles publicats > Diagnostic Accuracy of a Plasma Phosphorylated Tau 217 Immunoassay for Alzheimer Disease Pathology |
(Stavanger University Hospital (Noruega)) (University of Gothenburg (Suècia)) (ADx NeuroSciences (Ghent, Bèlgica)) (University of Gothenburg (Suècia)) (McGill University (Canadà)) (University of Pittsburgh (Estats Units d'Amèrica)) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (McGill University (Canadà)) (Sahlgrenska University Hospital (Suècia))| Data: | 2024 |
| Resum: | IMPORTANCE Phosphorylated tau (p-tau) is a specific blood biomarker for Alzheimer disease (AD) pathology, with p-tau217 considered to have the most utility. However, availability of p-tau217 tests for research and clinical use has been limited. Expanding access to this highly accurate AD biomarker is crucial for wider evaluation and implementation of AD blood tests. OBJECTIVE To determine the utility of a novel and commercially available immunoassay for plasma p-tau217 to detect AD pathology and evaluate reference ranges for abnormal amyloid β (Aβ) and longitudinal change across 3 selected cohorts. DESIGN, SETTING, AND PARTICIPANTS This cohort study examined data from 3 single-center observational cohorts: cross-sectional and longitudinal data from the Translational Biomarkers in Aging and Dementia (TRIAD) cohort (visits October 2017-August 2021) and Wisconsin Registry for Alzheimer's Prevention (WRAP) cohort (visits February 2007-November 2020) and cross-sectional data from the Sant Pau Initiative on Neurodegeneration (SPIN) cohort (baseline visits March 2009-November 2021). Participants included individuals with and without cognitive impairment grouped by amyloid and tau (AT) status using PET or CSF biomarkers. Data were analyzed from February to June 2023. EXPOSURES Magnetic resonance imaging, Aβ positron emission tomography (PET), tau PET, cerebrospinal fluid (CSF) biomarkers (Aβ42/40 and p-tau immunoassays), and plasma p-tau217 (ALZpath pTau217 assay). MAIN OUTCOMES AND MEASURES Accuracy of plasma p-tau217 in detecting abnormal amyloid and tau pathology, longitudinal p-tau217 change according to baseline pathology status. RESULTS The study included 786 participants (mean [SD] age, 66. 3 [9. 7] years; 504 females [64. 1%] and 282 males [35. 9%]). High accuracy was observed in identifying elevated Aβ (area under the curve [AUC], 0. 92-0. 96; 95% CI, 0. 89-0. 99) and tau pathology (AUC, 0. 93-0. 97; 95% CI, 0. 84-0. 99) across all cohorts. These accuracies were comparable with CSF biomarkers in determining abnormal PET signal. The detection of abnormal Aβ pathology using a 3-range reference yielded reproducible results and reduced confirmatory testing by approximately 80%. Longitudinally, plasma p-tau217 values showed an annual increase only in Aβ-positive individuals, with the highest increase observed in those with tau positivity. CONCLUSIONS AND RELEVANCE This study found that a commercially available plasma p-tau217 immunoassay accurately identified biological AD, comparable with results using CSF biomarkers, with reproducible cut-offs across cohorts. It detected longitudinal changes, including at the preclinical stage. |
| Ajuts: | Generalitat de Catalunya SLT006/17/00119 Generalitat de Catalunya SLT002/16/00408 Generalitat de Catalunya SLT006/17/125 European Commission H2020-SC1-BHC-2018-2020 Instituto de Salud Carlos III PI20/01330 Instituto de Salud Carlos III PI18/00435 Instituto de Salud Carlos III INT19/00016 Instituto de Salud Carlos III PI20/01473 European Commission 101053962 European Commission 860197 European Commission JPND2021-00694 |
| Nota: | Altres ajuts: Dr Blennow is supported by the Swedish Research Council (2017-00915 and 2022-00732), Swedish Alzheimer Foundation (AF-930351, AF-939721, and AF-968270), Hj\u00E4rnfonden, Sweden (FO2017-0243 and ALZ2022-0006), Swedish state under the agreement between the Swedish government and the County Councils, ALF-agreement (ALFGBG-715986 and ALFGBG-965240), European Union Joint Program for Neurodegenerative Disorders (JPND2019-466-236), Alzheimer\u2019s Association 2021 Zenith Award (ZEN-21-848495), and Alzheimer\u2019s Association 2022-2025 grant (SG-23-1038904 QC). Dr Zetterberg is a Wallenberg Scholar supported by grants from the Swedish Research Council (2022-01018 and 2019-02397), Swedish State Support for Clinical Research (ALFGBG-71320), Alzheimer Drug Discovery Foundation (201809-2016862), AD Strategic Fund, and Alzheimer\u2019s Association (ADSF-21-831376-C, ADSF-21-831381-C, and ADSF-21-831377-C), Bluefield Project, Olav Thon Foundation, Erling-Persson Family Foundation, Stiftelsen f\u00F6r Gamla Tj\u00E4narinnor, Hj\u00E4rnfonden, Sweden (FO2022-0270), and UK Dementia Research Institute at UCL (UKDRI-1003). |
| Drets: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.  |
| Llengua: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Matèria: | Aged ; Alzheimer Disease ; Amyloid ; Amyloid beta-Peptides ; Biomarkers ; Cognitive Dysfunction ; Cohort Studies ; Cross-Sectional Studies ; Female ; Humans ; Immunoassay ; Male ; Positron-Emission Tomography ; Tau Proteins |
| Publicat a: | JAMA Neurology, Vol. 81 Núm. 3 (november 2024) , p. 255-263, ISSN 2168-6157 |
