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Publications

Journal Article Epublish

PubMed: 40357140 DOI: 10.1002/dad2.70116

The two cut-offs approach for plasma p-tau217 in detecting Alzheimer's disease in subjective cognitive decline and mild cognitive impairment.

Alzheimers Dement (Amst) 17(2):e70116

Authors: Giulia Giacomucci, Chiara Crucitti, Assunta Ingannato, Valentina Moschini, Silvia Bagnoli, Federico Emanuele Pozzi, Elisa Marcantelli, Sonia Padiglioni, Carmen Morinelli, Salvatore Mazzeo, Sandro Sorbi, Valentina Berti, Benedetta Nacmias, Valentina Bessi

Affiliations

  • Department of Neuroscience, Psychology, Drug Research and Child Health University of Florence Florence Italy.
  • Research and Innovation Centre for Dementia-CRIDEM, AOU Careggi Florence Italy.
  • SOD Neurologia I Dipartimento Neuromuscolo-Scheletrico e degli Organi di Senso AOU Careggi Florence Italy.
  • Department of Neurology, Fondazione IRCCS San Gerardo dei Tintori Monza Italy.
  • Milan Center for Neuroscience (NeuroMI) University of Milano-Bicocca Milan Italy.
  • Regional Referral Centre for Relational Criticalities Tuscany Region Florence Italy.
  • Vita-Salute San Raffaele University Milan Italy.
  • IRCCS Policlinico San Donato San Donato Milanese Italy.
  • IRCCS Fondazione Don Carlo Gnocchi Florence Italy.
  • Department of Biomedical Experimental and Clinical Sciences "Mario Serio," University of Florence Florence Italy.
  • Nuclear Medicine Unit Azienda Ospedaliero-Universitaria Careggi Florence Italy.

Abstract

BACKGROUND

The study aimed to explore the applicability of plasma phosphorylated tau (p-tau)217 in identifying patients with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) carrying Alzheimer's disease (AD) pathology in real-world settings.

METHODS

Fifty SCD, 87 MCI, and 50 AD-demented patients underwent blood collection to dose plasma p-tau217 with a fully automated Lumipulse G600II assay. Patients were classified according to the Revised Criteria of the Alzheimer's Association Workgroup as Core1+ or Core1- (based on amyloid positron emission tomography, cerebrospinal fluid [CSF] amyloid beta [Aβ]42/Aβ40, CSF p-tau181/Aβ42).

RESULTS

Plasma p-tau217 was accurate for discriminating between Core1+ and Core1- patients (area under the curve = 0.92) with an optimal cut-off value of 0.274 pg/mL, revealing good accuracy (86.29%), positive predictive value (PPV; 88.18%), and negative predictive value (NPV; 83.09%). The two cut-offs approach (0.229-0.516 pg/mL) showed higher accuracy (91.11%), a PPV of 96.25% and a NPV of 83.63%.

CONCLUSION

The two cut-offs approach provides for stronger accuracy, PPV, and NPV than a single cut-off, making reliable the clinical application of plasma p-tau217 for early detection of AD in real-world settings.

Highlights

Plasma phosphorylated tau (p-tau)217 was highly accurate in detecting Alzheimer's disease (AD) pathology.The two cut-offs approach increased plasma p-tau217 accuracy for AD diagnosis.Even when measured with immunoassay, p-tau217 is a good biomarker for AD diagnosis.Transition of p-tau217 from research setting to clinical practice seems feasible.

MeSH

Alzheimer Disease, Pathology, Cognitive Dysfunction, Predictive Value Of Tests, Cognition Disorders, Amyloid, Plasma