Giacomucci Giulia, Crucitti Chiara, Ingannato Assunta, Moschini Valentina, Bagnoli Silvia, Pozzi Federico Emanuele, Marcantelli Elisa, Padiglioni Sonia, Morinelli Carmen, Mazzeo Salvatore, Sorbi Sandro, Berti Valentina, Nacmias Benedetta, Bessi Valentina
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.
Alzheimers Dement (Amst). 2025 May 11;17(2):e70116. doi: 10.1002/dad2.70116. eCollection 2025 Apr-Jun.
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.
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).
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%.
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.
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.
本研究旨在探讨血浆磷酸化tau（p-tau）217在现实环境中识别患有主观认知下降（SCD）和轻度认知障碍（MCI）且携带阿尔茨海默病（AD）病理特征患者的适用性。
50例SCD患者、87例MCI患者和50例AD痴呆患者接受采血，采用全自动Lumipulse G600II检测法测定血浆p-tau217。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[CSF]淀粉样β蛋白[Aβ]42/Aβ40、CSF p-tau181/Aβ42）。
血浆p-tau217在区分Core1+和Core1-患者方面具有准确性（曲线下面积=0.92），最佳截断值为0.274 pg/mL，显示出良好的准确性（86.29%）、阳性预测值（PPV；88.18%）和阴性预测值（NPV；83.09%）。双截断值法（0.229 - 0.516 pg/mL）显示出更高的准确性（91.11%），PPV为96.25%，NPV为83.63%。
双截断值法比单截断值法具有更高的准确性、PPV和NPV，使得血浆p-tau217在现实环境中用于AD早期检测的临床应用具有可靠性。
血浆磷酸化tau（p-tau）217在检测阿尔茨海默病（AD）病理特征方面具有高度准确性。双截断值法提高了血浆p-tau217对AD诊断的准确性。即使采用免疫测定法测量，p-tau217也是AD诊断的良好生物标志物。p-tau217从研究环境向临床实践的转变似乎是可行的。
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