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

• Published in: medRxiv : the preprint server for health sciences
• Main Authors: Gonzalez-Ortiz, Fernando, Ferreira, Pamela C L, Gonzalez, Armand, Montoliu-Gaya, Laia, Ortiz-Romero, Paula, Kac, Przemyslaw R, Turton, Michael, Kvartsberg, Hlin, Ashton, Nicholas J, Zetterberg, Henrik, Harrison, Peter, Bellaver, Bruna, Povala, Guilherme, Villemagne, Victor L, Pascoal, Tharick A, Ganguli, Mary, Cohen, Anne D, Miguillon, Carolina, Contador, Jose, Suarez-Calvet, Marc, Karikari, Thomas K, Blennow, Kaj
• Format: Journal Article
• Language: English
• Published: United States 05.10.2023
• DOI: 10.1101/2023.09.26.23296134

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. 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). 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). 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.