The impact of tau-PET in a selected memory clinic cohort: rationale and design of the TAP-TAU study.

IF 7.9 1区医学 Q1 CLINICAL NEUROLOGY

Alzheimer's Research & Therapy Pub Date : 2024-10-19 DOI:10.1186/s13195-024-01588-4

Marie R Vermeiren, Joost Somsen, Gert Luurtsema, Fransje E Reesink, Nicolaas A Verwey, Liesbeth Hempenius, Nelleke Tolboom, Geert Jan Biessels, J Matthijs Biesbroek, Meike W Vernooij, Sophie E M Veldhuijzen van Zanten, Harro Seelaar, Emma M Coomans, Charlotte E Teunissen, Afina W Lemstra, Argonde C van Harten, Leonie N C Visser, Wiesje M van der Flier, Elsmarieke van de Giessen, Rik Ossenkoppele

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引用次数: 0

Abstract

Background: Tau-PET is a diagnostic tool with high sensitivity and specificity for discriminating Alzheimer's disease (AD) dementia from other neurodegenerative disorders in well-controlled research environments. The role of tau-PET in real-world clinical practice, however, remains to be established. The aim of the TAP-TAU study is therefore to investigate the impact of tau-PET in clinical practice.

Methods: TAP-TAU is a prospective, longitudinal multi-center study in 300 patients (≥ 50 years old) with mild cognitive impairment or mild dementia across five Dutch memory clinics. Patients are eligible if diagnostic certainty is < 85% after routine dementia screening and if the differential diagnosis includes AD. More specifically, we will include patients who (i) are suspected of having mixed pathology (e.g., AD and vascular pathology), (ii) have an atypical clinical presentation, and/or (iii) show conflicting or inconclusive outcomes on other tests (e.g., magnetic resonance imaging or cerebrospinal fluid). Participants will undergo a [¹⁸F]flortaucipir tau-PET scan, blood-based biomarker sampling, and fill out questionnaires on patient reported outcomes and experiences. The primary outcomes are change (pre- versus post- tau-PET) in diagnosis, diagnostic certainty, patient management and patient anxiety and uncertainty. Secondary outcome measures are head-to-head comparisons between tau-PET and less invasive and lower cost diagnostic tools such as novel blood-based biomarkers and artificial intelligence-based classifiers.

Results: TAP-TAU has been approved by the Medical Ethics Committee of the Amsterdam UMC. The first participant is expected to be included in October 2024.

Conclusions: In TAP-TAU, we will investigate the added clinical value of tau-PET in a real-world clinical setting, including memory clinic patients with diagnostic uncertainty after routine work-up. Findings of our study may contribute to recommendations regarding which patients would benefit most from assessment with tau-PET. This study is timely in the dawning era of disease modifying treatments as an accurate etiological diagnosis becomes increasingly important.

Trial registration: This trial is registered and authorized on December 21st, 2023 in EU Clinical Trials with registration number 2023-505430-10-00.

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tau-PET 对特定记忆门诊队列的影响：TAP-TAU 研究的原理和设计。

背景：Tau-PET是一种诊断工具，在控制良好的研究环境中，它具有很高的灵敏度和特异性，可将阿尔茨海默病（AD）痴呆与其他神经退行性疾病区分开来。然而，tau-PET 在实际临床实践中的作用仍有待确定。因此，TAP-TAU 研究旨在调查 tau-PET 在临床实践中的影响：TAP-TAU 是一项前瞻性纵向多中心研究，研究对象是荷兰五家记忆诊所的 300 名轻度认知障碍或轻度痴呆患者（≥ 50 岁）。如果诊断确定为 18F]flortaucipir tau-PET 扫描、基于血液的生物标记物采样和填写患者报告结果和经历的调查问卷，则患者符合条件。主要结果是诊断、诊断确定性、患者管理以及患者焦虑和不确定性的变化（tau-PET 扫描前与扫描后）。次要结果指标是 tau-PET 与创伤性较小、成本较低的诊断工具（如基于血液的新型生物标记物和基于人工智能的分类器）之间的正面比较：TAP-TAU已获得阿姆斯特丹UMC医学伦理委员会的批准。第一位参与者预计将于 2024 年 10 月加入：在 TAP-TAU 中，我们将研究 tau-PET 在实际临床环境中的附加临床价值，包括常规检查后诊断不确定的记忆门诊患者。我们的研究结果可能有助于推荐哪些患者最受益于 tau-PET 评估。随着准确的病因诊断变得越来越重要，这项研究在疾病调整治疗的黎明时代非常及时：本试验于 2023 年 12 月 21 日在欧盟临床试验机构注册并获得授权，注册号为 2023-505430-10-00。

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 Research & Therapy 医学-神经病学

CiteScore

13.10

自引率

3.30%

发文量

172

审稿时长

>12 weeks

期刊介绍： Alzheimer's Research & Therapy is an international peer-reviewed journal that focuses on translational research into Alzheimer's disease and other neurodegenerative diseases. It publishes open-access basic research, clinical trials, drug discovery and development studies, and epidemiologic studies. The journal also includes reviews, viewpoints, commentaries, debates, and reports. All articles published in Alzheimer's Research & Therapy are included in several reputable databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, MEDLINE, PubMed, PubMed Central, Science Citation Index Expanded (Web of Science) and Scopus.