First of all, we know that the scenario concerning Alzheimer’s disease has drastically changed with the publication of the revised criteria of Alzheimer’s disease for the diagnosing and staging of Alzheimer’s disease. And in this criteria, one of the major changes is the introduction of plasma biomarkers for diagnosing and staging AD. And so what we wanted to explore with our study was to highlight the diagnostic accuracy of plasma P-tau217 in a real-world population, in a real-world memory clinic...
First of all, we know that the scenario concerning Alzheimer’s disease has drastically changed with the publication of the revised criteria of Alzheimer’s disease for the diagnosing and staging of Alzheimer’s disease. And in this criteria, one of the major changes is the introduction of plasma biomarkers for diagnosing and staging AD. And so what we wanted to explore with our study was to highlight the diagnostic accuracy of plasma P-tau217 in a real-world population, in a real-world memory clinic. Because to migrate the use of plasma P-tau217 and in general of plasma biomarkers from the research setting to clinical practice, we have to address some specific issues. First, the development of commercial tools, so commercial immunoassays, the development of specific cut-offs that could be validated in real-world populations and then validate this cut-off also in prodromal and preclinical stages of the disease such as mild cognitive impairment or subjective cognitive decline, where the prevalence of Alzheimer’s disease is lower than in demented patients, so the situation is completely different. So for this purpose, we enrolled and we collected plasma samples of patients with subjective cognitive decline, mild cognitive impairment, and Alzheimer’s disease demented patients, and who obviously underwent the clinical evaluation, the neuropsychological assessment, and the CSF analysis and/or the amyloid PET scans. Then, first of all, we evaluated the levels of plasma P-tau217, considering both the clinical and the biological diagnosis. So we compared the plasma P-tau217 levels in SCD or MCI patients’ carriers and non-carriers of AD pathology. And obviously, we found that plasma P-tau217 were higher in patients carrying AD pathology than in non-carriers, independently from the clinical stage. So this might be explained by the fact that plasma P-tau217 are influenced by the underlying pathology and not by the clinical status. There are some specific requirements for you to use plasma biomarkers in clinical practice. And to address some specific requirements, we try to apply the two cut-off approach in order to increase the accuracy of these plasma P-tau217 biomarkers. And also in our memory clinic, so in our real-world population, and using a commercial immunoassay, the Fujirebio ones, the plasma P-tau217 showed an excellent accuracy, an excellent positive predictive value. So, that’s respecting the requirement of the Alzheimer’s disease global CO for the diagnostic performance of the blood-based biomarkers for diagnostic use.
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