TY - JOUR
T1 - The strategic biomarker roadmap for the validation of Alzheimer’s diagnostic biomarkers: methodological update
AU - Boccardi, Marina
AU - Dodich, Alessandra
AU - Albanese, Emiliano
AU - Gayet-Ageron, Angèle
AU - Festari, Cristina
AU - Ashton, Nicholas J.
AU - Bischof, G. rard N.
AU - Chiotis, Konstantinos
AU - Leuzy, Antoine
AU - Wolters, Emma E.
AU - Walter, Martin A.
AU - Rabinovici, Gil D.
AU - Carrillo, Maria
AU - Drzezga, Alexander
AU - Hansson, Oskar
AU - Nordberg, Agneta
AU - Ossenkoppele, Rik
AU - Villemagne, Victor L.
AU - Winblad, Bengt
AU - Frisoni, Giovanni B.
AU - Garibotto, Valentina
N1 - Funding Information: Henryk Barthel1, Julie Corre2, Matteo Cotta-Ramusino3-4, Jean-Fran?ois Demonet5, Anton Gietl6, Thomas K Karikari7, Marco Lorenzi8, Osman Ratib9, Osama Sabri1, Valerie Treyer10, Paul G Unschuld11-41Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany2CNRS - Centre National de la Recherche Scientifique, Montpellier, France3Department of Brain and Behaviour, University of Pavia, Pavia, Italy4Unit of General Neurology, IRCCS Mondino Foundation, Pavia, Italy5Leenaards Memory Centre, Department of clinical neurosciences, University Hospital Centre (CHUV) and University of Lausanne (UNIL), Switzerland6Institute for Regenerative Medicine (IREM), University of Zurich, Schlieren, Switzerland7Department of Psychiatry and Neurochemistry, Institute of Neuroscience & Physiology, the Sahlgrenska Academy at the University of Gothenburg, M?lndal, Sweden8Epione Team, Inria Sophia Antipolis, Sophia Antipolis, France9Nuclear Medicine and Molecular Imaging Division, Department of Medical Imaging, University Hospitals of Geneva, Gen?ve, Switzerland10Department of Nuclear Medicine, University Hospital Zurich, Zurich, Switzerland11Division of Geriatric Psychiatry, University Hospital of Geneva (HUG), Geneva, Switzerland,12Institute for Regenerative Medicine (IREM), University of Zurich, Schlieren, Switzerland,13Psychiatric University Hospital Zurich (PUK), Zurich, Switzerland,14Institute for Biomedical Engineering (IBT), ETH, Zurich, Switzerland. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
KW - Alzheimer’s disease
KW - Biomarker
KW - Dementia
KW - MCI
KW - Mild cognitive impairment
KW - Validation methodology
UR - http://www.scopus.com/inward/record.url?scp=85102433062&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00259-020-05120-2
DO - https://doi.org/10.1007/s00259-020-05120-2
M3 - Article
C2 - 33688996
SN - 1619-7070
VL - 48
SP - 2070
EP - 2085
JO - European journal of nuclear medicine and molecular imaging
JF - European journal of nuclear medicine and molecular imaging
IS - 7
ER -