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Neuroimaging biomarkers for clinical trials in atypical parkinsonian disorders: Proposal for a Neuroimaging Biomarker Utility System

Lookup NU author(s): Professor Nicola PaveseORCiD

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

© 2019 The Authors 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.


Publication metadata

Author(s): van Eimeren T, Antonini A, Berg D, Bohnen N, Ceravolo R, Drzezga A, Hoglinger GU, Higuchi M, Lehericy S, Lewis S, Monchi O, Nestor P, Ondrus M, Pavese N, Peralta MC, Piccini P, Pineda-Pardo JA, Rektorova I, Rodriguez-Oroz M, Rominger A, Seppi K, Stoessl AJ, Tessitore A, Thobois S, Kaasinen V, Wenning G, Siebner HR, Strafella AP, Rowe JB

Publication type: Article

Publication status: Published

Journal: Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring

Year: 2019

Volume: 11

Pages: 301-309

Print publication date: 01/12/2019

Online publication date: 02/04/2019

Acceptance date: 02/04/2019

Date deposited: 15/04/2019

ISSN (electronic): 2352-8729

Publisher: Elsevier Inc

URL: https://doi.org/10.1016/j.dadm.2019.01.011

DOI: 10.1016/j.dadm.2019.01.011


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Funding

Funder referenceFunder name
#1110414
101 RX000317
Agency of Health Research of the Ministry of Health
Aguettant
AbbVie
Biogen-Idec
BMWi
ANR
ANR-10-IAIHU-06
ANR-11-INBS-0006
AZ-Medimmune
BMBF
Canada Research Chair Program
Chisei Pharmaceuticals
Damp foundation
EU Joint Program of Neurodegenerative Diseases
Fondation pour la Recherche Medicale
France Parkinson
German Parkinson's Disease Association
EU
H2020-MSCA RISE
Foundation Neurodis
IMI H2020
Janssen Pharmaceutica N.V.
Horizon2020
JPND
Medical Research Council
Medtronic
Michael J. Fox Foundation
MOP-136778
Lundbeck
National Institute for Health Research
NovartisNovartis Pharma AG
Novartis Pharma GmbH
P50 NS091856
PHRC
St Jude
Parkinson Fonds Deutschland gGmbH
TEVA Pharma GmbH
UCB
RO1 NS070856
Teva
UCB Pharma GmbH
Wellcome Trust
Zambon

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