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
{"title":"tau-PET 对特定记忆门诊队列的影响：TAP-TAU 研究的原理和设计。","authors":"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","doi":"10.1186/s13195-024-01588-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 [<sup>18</sup>F]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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>This trial is registered and authorized on December 21st, 2023 in EU Clinical Trials with registration number 2023-505430-10-00.</p>","PeriodicalId":7516,"journal":{"name":"Alzheimer's Research & Therapy","volume":"16 1","pages":"230"},"PeriodicalIF":7.9000,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11490118/pdf/","citationCount":"0","resultStr":"{\"title\":\"The impact of tau-PET in a selected memory clinic cohort: rationale and design of the TAP-TAU study.\",\"authors\":\"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\",\"doi\":\"10.1186/s13195-024-01588-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 [<sup>18</sup>F]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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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This study is timely in the dawning era of disease modifying treatments as an accurate etiological diagnosis becomes increasingly important.</p><p><strong>Trial registration: </strong>This trial is registered and authorized on December 21st, 2023 in EU Clinical Trials with registration number 2023-505430-10-00.</p>\",\"PeriodicalId\":7516,\"journal\":{\"name\":\"Alzheimer's Research & Therapy\",\"volume\":\"16 1\",\"pages\":\"230\"},\"PeriodicalIF\":7.9000,\"publicationDate\":\"2024-10-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11490118/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Alzheimer's Research & Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13195-024-01588-4\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alzheimer's Research & Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13195-024-01588-4","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
The impact of tau-PET in a selected memory clinic cohort: rationale and design of the TAP-TAU study.
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.
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.
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