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[Preprint]. 2023 Oct 5:2023.09.26.23296134. [Version 2] doi: 10.1101/2023.09.26.23296134

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

Fernando Gonzalez-Ortiz, Pamela C L Ferreira, Armand Gonzalez, Laia Montoliu-Gaya, Paula Ortiz-Romero, Przemyslaw R Kac, Michael Turton, Hlin Kvartsberg, Nicholas J Ashton, Henrik Zetterberg, Peter Harrison, Bruna Bellaver, Guilherme Povala, Victor L Villemagne, Tharick A Pascoal, Mary Ganguli, Anne D Cohen, Carolina Miguillon, Jose Contador, Marc Suarez-Calvet, Thomas K Karikari, Kaj Blennow
PMCID: PMC10593040  PMID: 37873312

ABSTRACT

INTRODUCTION

Detection of Alzheimer’s disease (AD) pathophysiology among cognitively unimpaired individuals and those experiencing subjective cognitive decline (SCD) remains challenging. Plasma 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 (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 participants (MYHAT and Pittsburgh), and a population-based cohort of individuals with SCD (β-AARC).

RESULTS

UGOT p-tau217 showed high accuracy (AUC= 0.80-0.91) identifying 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.

Full Text Availability

The license terms selected by the author(s) for this preprint version do not permit archiving in PMC. The full text is available from the preprint server.


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