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

Groot, Colin LU ; Cicognola, Claudia LU orcid ; Bali, Divya LU ; Triana-Baltzer, Gallen ; Dage, Jeffrey L ; Pontecorvo, Michael J ; Kolb, Hartmuth C ; Osssenkoppele, Rik ; Janelidze, Shorena LU and Hansson, Oskar LU orcid (2022) In Alzheimer's Research & Therapy 14(1). p.1-12
Abstract

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... (More)

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+
Janssenr = -0.45 vs p-tau217
Lillyr = -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.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alzheimer Disease/psychology, Amyloid beta-Peptides, Biomarkers, Cognitive Dysfunction/psychology, Disease Progression, Humans, Prognosis, tau Proteins
in
Alzheimer's Research & Therapy
volume
14
issue
1
article number
67
pages
1 - 12
publisher
BioMed Central (BMC)
external identifiers
  • pmid:35568889
  • scopus:85130040353
ISSN
1758-9193
DOI
10.1186/s13195-022-01005-8
language
English
LU publication?
yes
additional info
© 2022. The Author(s).
id
423ad3f4-8a4a-4c6b-b92b-8e4ae8db022f
date added to LUP
2022-05-21 16:09:04
date last changed
2025-05-02 19:28:50
@article{423ad3f4-8a4a-4c6b-b92b-8e4ae8db022f,
  abstract     = {{<p>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+<br>
 Janssen, and perform a head-to-head comparison to an established assay, plasma p-tau217<br>
 Lilly, within two independent cohorts<br>
 . 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.<br>
 </p><p>RESULTS: Both assays showed similar performance in detecting amyloid-β status in CSF (plasma p-tau217+<br>
 Janssen AUC = 0.91 vs plasma p-tau217<br>
 Lilly AUC = 0.89), distinguishing MCI from controls (plasma p-tau217+<br>
 Janssen AUC = 0.91 vs plasma p-tau217<br>
 Lilly AUC = 0.91), and predicting future conversion from MCI to AD dementia (plasma p-tau217+<br>
 Janssen AUC = 0.88 vs p-tau217<br>
 Lilly AUC = 0.89). Both assays were similarly related to baseline (plasma p-tau217+<br>
 Janssen rho = -0.39 vs p-tau217<br>
 Lilly rho = -0.35), and annual change in MMSE scores (plasma p-tau217+<br>
 Janssenr = -0.45 vs p-tau217<br>
 Lillyr = -0.41). Correlations between the two plasma measures were rho = 0.69, p &lt; 0.001 in cohort 1 and rho = 0.70, p &lt; 0.001 in cohort 2. Bland-Altmann plots revealed good agreement between plasma p-tau217+ <br>
 Janssen and plasma p-tau217<br>
 Lilly in both cohorts (cohort 1, 51/52 [98%] within 95%CI; cohort 2, 139/147 [95%] within 95%CI).<br>
 </p><p>CONCLUSIONS: Taken together, our results indicate good diagnostic and prognostic performance of the plasma p-tau217+<br>
 Janssen assay, similar to the p-tau217<br>
 Lilly assay.<br>
 </p>}},
  author       = {{Groot, Colin and Cicognola, Claudia and Bali, Divya and Triana-Baltzer, Gallen and Dage, Jeffrey L and Pontecorvo, Michael J and Kolb, Hartmuth C and Osssenkoppele, Rik and Janelidze, Shorena and Hansson, Oskar}},
  issn         = {{1758-9193}},
  keywords     = {{Alzheimer Disease/psychology; Amyloid beta-Peptides; Biomarkers; Cognitive Dysfunction/psychology; Disease Progression; Humans; Prognosis; tau Proteins}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{1--12}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Alzheimer's Research & Therapy}},
  title        = {{Diagnostic and prognostic performance to detect Alzheimer's disease and clinical progression of a novel assay for plasma p-tau217}},
  url          = {{http://dx.doi.org/10.1186/s13195-022-01005-8}},
  doi          = {{10.1186/s13195-022-01005-8}},
  volume       = {{14}},
  year         = {{2022}},
}