The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update

Article Article scientifique Article The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update eng 2021-03-10 2021-07 author Boccardi Marina 850343 author Dodich Alessandra 896999 author Albanese Emiliano 811015 author Gayet-Ageron Angèle 0000-0002-6164-9693 668551 author Festari Cristina 954896 author Ashton Nicholas J author Bischof Gérard N author Chiotis Konstantinos author Leuzy Antoine author Wolters Emma E author Walter Martin A author Rabinovici Gil D author Carrillo Maria author Drzezga Alexander author Hansson Oskar author Nordberg Agneta author Ossenkoppele Rik author Villemagne Victor L author Winblad Bengt author Frisoni Giovanni 810190 author Garibotto Valentina 0000-0003-2422-698X 704817 2070-2085 10.1007/s00259-020-05120-2 33688996 1619-7070 PMC8175304 https://link.springer.com/article/10.1007%2Fs00259-020-05120-2 Background: The 2017 Alzheimer's disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1-2), clinical validity (Phases 3-4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research. Methods: We critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer's Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers. Results: The 2020 update applies to all AD diagnostic biomarkers. In Phases 2-3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures. Discussion: This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics. Alzheimer's disease Biomarker Dementia MCI Mild cognitive impairment Validation methodology Alzheimer Disease / diagnosis Amyloid beta-Peptides Biomarkers Cognitive Dysfunction Cross-Sectional Studies Disease Progression Humans Reference Standards Tau Proteins Dewey 613 Dewey 616.0757 Dewey 618.97 Swiss National Science Foundation Strategic roadmap for the translation of tau biomarkers in the clinic: an international task force 188355 CH Science communication Swiss National Science Foundation The Biological Basis of Cognitive Impairment due to Suspected Non-Alzheimer’s Pathology (SNAP) : Studying the interplay between amyloidosis and tau-related neurodegeneration 169876 CH Projects Swiss National Science Foundation Individual cognitive risk profiling in aging according to Amyloid, Tau and Neurodegeneration imaging biomarkers 185028 CH Projects European Commission Amyloid imaging to Prevent Alzheimer’s Disease – Sofia ref.: 115952 115952 AMYPAD EU H2020 Autre Alzheimer's Association, OsiriX Foundation, APRA (Association Suisse pour la Recherche sur l'Alzheimer) 62 Département de radiologie et informatique médicale 227 64 Département de santé et médecine communautaires 22A 65 Département de réadaptation et gériatrie 22B false 88 Epidémiologie clinique et biostatistique 115 1222 Laboratoire de neuroimagerie et de traceurs moléculaires innovants 984 853 Troubles de mémoire et maladie d'Alzeimer 935 European Journal of Nuclear Medicine and Molecular Imaging 48 7 27748fc6-d7d1-4cd4-b145-17d09ad656a4 Article (Published version) Public Boccardi2021_Article_TheStrategicBiomarkerRoadmapFo-1.pdf 456377 application/pdf CC BY 938799be-e4d7-4c1e-b0fd-45ac1be3be83 Corrigendum Public Article-scientifique-from-europePmc.pdf 644224 application/pdf c3f1fde45c4c2192b24e018739896eee4d61b34ad315ea78ef5d7044b3dc3589 The authors regret Table 2 needs to be rearranged so that it will be easier to be understood. 10.1007/s00259-021-05549-z 34546388 openAccess Faculté de médecine / Section de médecine clinique / Département de radiologie et informatique médicale Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires Faculté de médecine / Section de médecine clinique / Département de réadaptation et gériatrie

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The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update	European Journal of Nuclear Medicine and Molecular Imaging			2021	361	327

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