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Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217

BACKGROUND: Recent advances in disease-modifying treatments highlight the need for accurately identifying individuals in early Alzheimer’s disease (AD) stages and for monitoring of treatment effects. Plasma measurements of phosphorylated tau (p-tau) are a promising biomarker for AD, but different as...

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Autores principales: Groot, Colin, Cicognola, Claudia, Bali, Divya, Triana-Baltzer, Gallen, Dage, Jeffrey L., Pontecorvo, Michael J., Kolb, Hartmuth C., Osssenkoppele, Rik, Janelidze, Shorena, Hansson, Oskar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9107269/
https://www.ncbi.nlm.nih.gov/pubmed/35568889
http://dx.doi.org/10.1186/s13195-022-01005-8
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author Groot, Colin
Cicognola, Claudia
Bali, Divya
Triana-Baltzer, Gallen
Dage, Jeffrey L.
Pontecorvo, Michael J.
Kolb, Hartmuth C.
Osssenkoppele, Rik
Janelidze, Shorena
Hansson, Oskar
author_facet Groot, Colin
Cicognola, Claudia
Bali, Divya
Triana-Baltzer, Gallen
Dage, Jeffrey L.
Pontecorvo, Michael J.
Kolb, Hartmuth C.
Osssenkoppele, Rik
Janelidze, Shorena
Hansson, Oskar
author_sort Groot, Colin
collection PubMed
description BACKGROUND: Recent advances in disease-modifying treatments highlight the need for accurately identifying individuals in early Alzheimer’s disease (AD) stages and for monitoring of treatment effects. Plasma measurements of phosphorylated tau (p-tau) are a promising biomarker for AD, but different assays show varying diagnostic and prognostic accuracies. The objective of this study was to determine the clinical performance of a novel plasma p-tau217 (p-tau217) assay, p-tau217+(Janssen), and perform a head-to-head comparison to an established assay, plasma p-tau217(Lilly), within two independent cohorts(.) METHODS: The study consisted of two cohorts, cohort 1 (27 controls and 25 individuals with mild-cognitive impairment [MCI]) and cohort 2 including 147 individuals with MCI at baseline who were followed for an average of 4.92 (SD 2.09) years. Receiver operating characteristic analyses were used to assess the performance of both assays to detect amyloid-β status (+/−) in CSF, distinguish MCI from controls, and identify subjects who will convert from MCI to AD dementia. General linear and linear mixed-effects analyses were used to assess the associations between p-tau and baseline, and annual change in Mini-Mental State Examination (MMSE) scores. Spearman correlations were used to assess the associations between the two plasma measures, and Bland-Altmann plots were examined to assess the agreement between the assays. RESULTS: Both assays showed similar performance in detecting amyloid-β status in CSF (plasma p-tau217+(Janssen) AUC = 0.91 vs plasma p-tau217(Lilly) AUC = 0.89), distinguishing MCI from controls (plasma p-tau217+(Janssen) AUC = 0.91 vs plasma p-tau217(Lilly) AUC = 0.91), and predicting future conversion from MCI to AD dementia (plasma p-tau217+(Janssen) AUC = 0.88 vs p-tau217(Lilly) AUC = 0.89). Both assays were similarly related to baseline (plasma p-tau217+(Janssen) rho = −0.39 vs p-tau217(Lilly) rho = −0.35), and annual change in MMSE scores (plasma p-tau217+(Janssen)r = −0.45 vs p-tau217(Lilly)r = −0.41). Correlations between the two plasma measures were rho = 0.69, p < 0.001 in cohort 1 and rho = 0.70, p < 0.001 in cohort 2. Bland-Altmann plots revealed good agreement between plasma p-tau217+(Janssen) and plasma p-tau217(Lilly) in both cohorts (cohort 1, 51/52 [98%] within 95%CI; cohort 2, 139/147 [95%] within 95%CI). CONCLUSIONS: Taken together, our results indicate good diagnostic and prognostic performance of the plasma p-tau217+(Janssen) assay, similar to the p-tau217(Lilly) assay. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13195-022-01005-8.
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spelling pubmed-91072692022-05-15 Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217 Groot, Colin Cicognola, Claudia Bali, Divya Triana-Baltzer, Gallen Dage, Jeffrey L. Pontecorvo, Michael J. Kolb, Hartmuth C. Osssenkoppele, Rik Janelidze, Shorena Hansson, Oskar Alzheimers Res Ther Research BACKGROUND: Recent advances in disease-modifying treatments highlight the need for accurately identifying individuals in early Alzheimer’s disease (AD) stages and for monitoring of treatment effects. Plasma measurements of phosphorylated tau (p-tau) are a promising biomarker for AD, but different assays show varying diagnostic and prognostic accuracies. The objective of this study was to determine the clinical performance of a novel plasma p-tau217 (p-tau217) assay, p-tau217+(Janssen), and perform a head-to-head comparison to an established assay, plasma p-tau217(Lilly), within two independent cohorts(.) METHODS: The study consisted of two cohorts, cohort 1 (27 controls and 25 individuals with mild-cognitive impairment [MCI]) and cohort 2 including 147 individuals with MCI at baseline who were followed for an average of 4.92 (SD 2.09) years. Receiver operating characteristic analyses were used to assess the performance of both assays to detect amyloid-β status (+/−) in CSF, distinguish MCI from controls, and identify subjects who will convert from MCI to AD dementia. General linear and linear mixed-effects analyses were used to assess the associations between p-tau and baseline, and annual change in Mini-Mental State Examination (MMSE) scores. Spearman correlations were used to assess the associations between the two plasma measures, and Bland-Altmann plots were examined to assess the agreement between the assays. RESULTS: Both assays showed similar performance in detecting amyloid-β status in CSF (plasma p-tau217+(Janssen) AUC = 0.91 vs plasma p-tau217(Lilly) AUC = 0.89), distinguishing MCI from controls (plasma p-tau217+(Janssen) AUC = 0.91 vs plasma p-tau217(Lilly) AUC = 0.91), and predicting future conversion from MCI to AD dementia (plasma p-tau217+(Janssen) AUC = 0.88 vs p-tau217(Lilly) AUC = 0.89). Both assays were similarly related to baseline (plasma p-tau217+(Janssen) rho = −0.39 vs p-tau217(Lilly) rho = −0.35), and annual change in MMSE scores (plasma p-tau217+(Janssen)r = −0.45 vs p-tau217(Lilly)r = −0.41). Correlations between the two plasma measures were rho = 0.69, p < 0.001 in cohort 1 and rho = 0.70, p < 0.001 in cohort 2. Bland-Altmann plots revealed good agreement between plasma p-tau217+(Janssen) and plasma p-tau217(Lilly) in both cohorts (cohort 1, 51/52 [98%] within 95%CI; cohort 2, 139/147 [95%] within 95%CI). CONCLUSIONS: Taken together, our results indicate good diagnostic and prognostic performance of the plasma p-tau217+(Janssen) assay, similar to the p-tau217(Lilly) assay. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13195-022-01005-8. BioMed Central 2022-05-14 /pmc/articles/PMC9107269/ /pubmed/35568889 http://dx.doi.org/10.1186/s13195-022-01005-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Groot, Colin
Cicognola, Claudia
Bali, Divya
Triana-Baltzer, Gallen
Dage, Jeffrey L.
Pontecorvo, Michael J.
Kolb, Hartmuth C.
Osssenkoppele, Rik
Janelidze, Shorena
Hansson, Oskar
Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title_full Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title_fullStr Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title_full_unstemmed Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title_short Diagnostic and prognostic performance to detect Alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
title_sort diagnostic and prognostic performance to detect alzheimer’s disease and clinical progression of a novel assay for plasma p-tau217
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9107269/
https://www.ncbi.nlm.nih.gov/pubmed/35568889
http://dx.doi.org/10.1186/s13195-022-01005-8
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