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Neuroimaging biomarkers for clinical trials in atypical parkinsonian disorders: Proposal for a Neuroimaging Biomarker Utility System
T. van Eimeren, A. Antonini, D. Berg, N. Bohnen, R. Ceravolo, A. Drzezga, GU. Höglinger, M. Higuchi, S. Lehericy, S. Lewis, O. Monchi, P. Nestor, M. Ondrus, N. Pavese, MC. Peralta, P. Piccini, JÁ. Pineda-Pardo, I. Rektorová, M. Rodríguez-Oroz, A....
Language English Country Netherlands
Document type Journal Article
Grant support
R01 NS070856
NINDS NIH HHS - United States
I01 RX001631
RRD VA - United States
I01 RX000317
RRD VA - United States
P50 NS091856
NINDS NIH HHS - United States
Wellcome Trust - United Kingdom
- Publication type
- Journal Article MeSH
Introduction: Therapeutic strategies targeting protein aggregations are ready for clinical trials in atypical parkinsonian disorders. Therefore, there is an urgent need for neuroimaging biomarkers to help with the early detection of neurodegenerative processes, the early differentiation of the underlying pathology, and the objective assessment of disease progression. However, there currently is not yet a consensus in the field on how to describe utility of biomarkers for clinical trials in atypical parkinsonian disorders. Methods: To promote standardized use of neuroimaging biomarkers for clinical trials, we aimed to develop a conceptual framework to characterize in more detail the kind of neuroimaging biomarkers needed in atypical parkinsonian disorders, identify the current challenges in ascribing utility of these biomarkers, and propose criteria for a system that may guide future studies. Results: As a consensus outcome, we describe the main challenges in ascribing utility of neuroimaging biomarkers in atypical parkinsonian disorders, and we propose a conceptual framework that includes a graded system for the description of utility of a specific neuroimaging measure. We included separate categories for the ability to accurately identify an intention-to-treat patient population early in the disease (Early), to accurately detect a specific underlying pathology (Specific), and the ability to monitor disease progression (Progression). Discussion: We suggest that the advancement of standardized neuroimaging in the field of atypical parkinsonian disorders will be furthered by a well-defined reference frame for the utility of biomarkers. The proposed utility system allows a detailed and graded description of the respective strengths of neuroimaging biomarkers in the currently most relevant areas of application in clinical trials.
1st Department of Neurology Faculty of Medicine and CEITEC MU Masaryk University Brno Czech Republic
AXON Neuroscience CRM Services SE Bratislava Slovak Republic
Brain and Mind Centre Sydney Medical School University of Sydney Sydney NSW Australia
Center for Medical Education and Clinical Research Section of Neurology Buenos Aires Argentina
Department of Clinical and Experimental Medicine University of Pisa Pisa Italy
Department of Clinical Neurosciences University of Cambridge Cambridge United Kingdom
Department of Medicine Imperial College London London United Kingdom
Department of Neurology Clinica Universidad de Navarra Pamplona Spain
Department of Neurology Medical University of Innsbruck Innsbruck Austria
Department of Neurology UKSH Campus Kiel Christian Albrechts University Kiel Germany
Department of Neuroscience University of Padua Padua Italy
Department of Nuclear Medicine Inselspital Universitätsspital Bern Bern Switzerland
hmCINAC University Hospital HM Puerta del Sur CEU San Pablo University Móstoles Madrid Spain
National Institutes for Quantum and Radiological Science and Technology Chiba Japan
Pacific Parkinson's Research Centre University of British Columbia Vancouver Canada
References provided by Crossref.org
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