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

Autor:	Vermeiren MR; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. m.r.vermeiren@amsterdamumc.nl.; Department of Radiology & Nuclear Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. m.r.vermeiren@amsterdamumc.nl.; Amsterdam Neuroscience, Brain Imaging, Amsterdam, Netherlands. m.r.vermeiren@amsterdamumc.nl., Somsen J; Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands., Luurtsema G; Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands., Reesink FE; Department of Neurology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands., Verwey NA; Department of Neurology, Medical Center Leeuwarden, Leeuwarden, Netherlands.; Amsterdam Neuroscience, Neurodegeneration, Amsterdam, Netherlands., Hempenius L; Geriatric Center, Medical Center Leeuwarden, Leeuwarden, Netherlands., Tolboom N; Department of Radiology and Nuclear Medicine, University Medical Centre Utrecht, Utrecht, Netherlands., Biessels GJ; Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, Netherlands., Biesbroek JM; Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.; Department of Neurology, Diakonessenhuis Hospital, Utrecht, Netherlands., Vernooij MW; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, Netherlands.; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, Netherlands., Veldhuijzen van Zanten SEM; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, Netherlands., Seelaar H; Department of Neurology, Erasmus University Medical Center, Rotterdam, Netherlands., Coomans EM; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.; Amsterdam Neuroscience, Brain Imaging, Amsterdam, Netherlands., Teunissen CE; Neurochemistry Laboratory, Amsterdam UMC, Amsterdam, Netherlands., Lemstra AW; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands., van Harten AC; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands., Visser LNC; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.; Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands., van der Flier WM; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.; Amsterdam Neuroscience, Neurodegeneration, Amsterdam, Netherlands.; Epidemiology and Data Science, Amsterdam UMC, Amsterdam, Netherlands., van de Giessen E; Department of Radiology & Nuclear Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.; Amsterdam Neuroscience, Brain Imaging, Amsterdam, Netherlands., Ossenkoppele R; Alzheimer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. r.ossenkoppele@amsterdamumc.nl.; Amsterdam Neuroscience, Brain Imaging, Amsterdam, Netherlands. r.ossenkoppele@amsterdamumc.nl.; Clinical Memory Research Unit, Lund University, Lund, Sweden. r.ossenkoppele@amsterdamumc.nl.
Jazyk:	angličtina
Zdroj:	Alzheimer's research & therapy [Alzheimers Res Ther] 2024 Oct 19; Vol. 16 (1), pp. 230. Date of Electronic Publication: 2024 Oct 19.
DOI:	10.1186/s13195-024-01588-4
Abstrakt:	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 [ 18 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. 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. (© 2024. The Author(s).)
Databáze:	MEDLINE
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