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

IF 4 Q1 CLINICAL NEUROLOGY

Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring Pub Date : 2025-05-11 eCollection Date: 2025-04-01 DOI:10.1002/dad2.70116

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

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引用次数: 0

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.

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血浆p-tau217检测阿尔茨海默病主观认知能力下降和轻度认知障碍的双截止方法

背景：本研究旨在探讨血浆磷酸化tau (p-tau)217在识别现实世界中伴有阿尔茨海默病（AD）病理的主观认知衰退（SCD）和轻度认知障碍（MCI）患者中的适用性。方法：50例SCD、87例MCI和50例ad痴呆患者采集血液，使用全自动Lumipulse G600II测定血浆p-tau217剂量。根据阿尔茨海默病协会工作组修订标准将患者分为Core1+或Core1-（基于淀粉样蛋白正电子发射断层扫描，脑脊液淀粉样蛋白β [Aβ]42/Aβ40，脑脊液p-tau181/Aβ42）。结果：血浆p-tau217可准确区分Core1+和Core1-患者（曲线下面积= 0.92），最佳临界值为0.274 pg/mL，准确度为86.29%，阳性预测值(PPV；88.18%)，阴性预测值(NPV；83.09%)。两种截断法（0.229 ~ 0.516 pg/mL）的准确率为91.11%，PPV为96.25%，NPV为83.63%。结论：与单一截止方法相比，双截止方法提供了更高的准确性、PPV和NPV，使血浆p-tau217在现实世界中早期检测AD的临床应用更加可靠。血浆磷酸化tau (p-tau)217在检测阿尔茨海默病（AD）病理方面具有很高的准确性。两个截断方法提高了血浆p-tau217对AD诊断的准确性。即使用免疫分析法测量，p-tau217也是一种很好的AD诊断生物标志物。将p-tau217从研究环境转移到临床实践似乎是可行的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring Medicine-Psychiatry and Mental Health

CiteScore

7.80

自引率

7.50%

发文量

101

审稿时长

8 weeks

期刊介绍： Alzheimer''s & Dementia: Diagnosis, Assessment & Disease Monitoring (DADM) is an open access, peer-reviewed, journal from the Alzheimer''s Association® that will publish new research that reports the discovery, development and validation of instruments, technologies, algorithms, and innovative processes. Papers will cover a range of topics interested in the early and accurate detection of individuals with memory complaints and/or among asymptomatic individuals at elevated risk for various forms of memory disorders. The expectation for published papers will be to translate fundamental knowledge about the neurobiology of the disease into practical reports that describe both the conceptual and methodological aspects of the submitted scientific inquiry. Published topics will explore the development of biomarkers, surrogate markers, and conceptual/methodological challenges. Publication priority will be given to papers that 1) describe putative surrogate markers that accurately track disease progression, 2) biomarkers that fulfill international regulatory requirements, 3) reports from large, well-characterized population-based cohorts that comprise the heterogeneity and diversity of asymptomatic individuals and 4) algorithmic development that considers multi-marker arrays (e.g., integrated-omics, genetics, biofluids, imaging, etc.) and advanced computational analytics and technologies.