TY - JOUR
T1 - Neuroimaging biomarkers for clinical trials in atypical parkinsonian disorders
T2 - Proposal for a Neuroimaging Biomarker Utility System
AU - van Eimeren, Thilo
AU - Antonini, Angelo
AU - Berg, Daniela
AU - Bohnen, Nico
AU - Ceravolo, Roberto
AU - Drzezga, Alexander
AU - Höglinger, Günter U
AU - Higuchi, Makoto
AU - Lehericy, Stephane
AU - Lewis, Simon
AU - Monchi, Oury
AU - Nestor, Peter
AU - Ondrus, Matej
AU - Pavese, Nicola
AU - Peralta, María Cecilia
AU - Piccini, Paola
AU - Pineda-Pardo, José Ángel
AU - Rektorová, Irena
AU - Rodríguez-Oroz, María
AU - Rominger, Axel
AU - Seppi, Klaus
AU - Stoessl, A Jon
AU - Tessitore, Alessandro
AU - Thobois, Stephane
AU - Kaasinen, Valtteri
AU - Wenning, Gregor
AU - Siebner, Hartwig R.
AU - Strafella, Antonio P
AU - Rowe, James B.
PY - 2019/12
Y1 - 2019/12
N2 - 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.
AB - 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.
U2 - 10.1016/j.dadm.2019.01.011
DO - 10.1016/j.dadm.2019.01.011
M3 - Journal article
C2 - 30984816
SN - 2352-8729
VL - 11
SP - 301
EP - 309
JO - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring
JF - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring
ER -