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

Author:

Gonzalez‐Ortiz Fernando12ORCID,Ferreira Pamela C. L.3,González‐Escalante Armand45,Montoliu‐Gaya Laia1,Ortiz‐Romero Paula45,Kac Przemyslaw R.1,Turton Michael6,Kvartsberg Hlin12,Ashton Nicholas J.1789,Zetterberg Henrik12101112,Harrison Peter6,Bellaver Bruna3,Povala Guilherme3,Villemagne Victor L.3,Pascoal Tharick A.313,Ganguli Mary314,Cohen Anne D.3,Minguillon Carolina4515,Contador Jose4516,Suárez‐Calvet Marc451516,Karikari Thomas K.13,Blennow Kaj12

Affiliation:

1. Department of Psychiatry and Neurochemistry Institute of Neuroscience and Physiology the Sahlgrenska Academy at the University of Gothenburg Gothenburg Sweden

2. Clinical Neurochemistry Laboratory Sahlgrenska University Hospital Gothenburg Sweden

3. Department of Psychiatry School of Medicine University of Pittsburgh Pittsburgh Pennsylvania USA

4. Barcelonaβeta Brain Research Center (BBRC) Pasqual Maragall Foundation Barcelona Spain

5. Hospital del Mar Research Institute Barcelona Spain

6. Bioventix Plc 7 Romans Business Park Farnham Surrey UK

7. Wallenberg Centre for Molecular and Translational Medicine University of Gothenburg Gothenburg Sweden

8. King's College London Institute of Psychiatry Psychology and Neuroscience Maurice Wohl Clinical Neuroscience Institute London UK

9. NIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation London UK

10. Department of Neurodegenerative Disease UCL Institute of Neurology Queen Square London UK

11. UK Dementia Research Institute at UCL London UK

12. Hong Kong Center for Neurodegenerative Diseases Clear Water Bay Hong Kong China

13. Department of Neurology, School of Medicine University of Pittsburgh Pittsburgh USA

14. Department of Epidemiology School of Public Health University of Pittsburgh Pittsburgh Pennsylvania USA

15. Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES) Madrid Spain

16. Cognitive Decline and Movement Disorders Unit Neurology Department Hospital del Mar Barcelona Spain

Abstract

AbstractINTRODUCTIONDetection of Alzheimer's disease (AD) pathophysiology among individuals with mild cognitive changes and those experiencing subjective cognitive decline (SCD) remains challenging. Plasma phosphorylated tau 217 (p‐tau217) is one of the most promising of the emerging biomarkers for AD. However, accessible methods are limited.METHODSWe employed a novel p‐tau217 immunoassay (University of Gothenburg [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 (CU) and mild cognitively impaired (MCI) participants (MYHAT and Pittsburgh), and a population‐based cohort of individuals with SCD (Barcelonaβeta Brain Research Center's Alzheimer's At‐Risk Cohort [β‐AARC]).RESULTSUGOT p‐tau217 showed high accuracy (area under the curve [AUC] = 0.80–0.91) identifying amyloid beta (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).DISCUSSIONUGOT 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.

Funder

Vetenskapsrådet

Alzheimer's Association

National Institutes of Health

Publisher

Wiley

Subject

Psychiatry and Mental health,Cellular and Molecular Neuroscience,Geriatrics and Gerontology,Neurology (clinical),Developmental Neuroscience,Health Policy,Epidemiology

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