Category: Parkinson's Disease: Neuroimaging
Objective: To develop consensus recommendations for neuroimaging biomarkers suitable for use in Parkinson’s disease (PD) drug development.
Background: Given the anticipated rise in PD prevalence in the coming decades and reliance on symptomatic treatments, there is an urgent need for new therapies to slow or halt its progression. Neuroimaging biomarkers are of particular interest in drug development, as they provide unique regionally specific biological information antemortem that can be used to optimize the drug development process. Dopaminergic imaging is a prominent tool in PD diagnosis and trial enrichment; however, the pathophysiology of PD is complex and other emerging neuroimaging methods may complement dopaminergic imaging.
Method: The Critical Path for Parkinson’s Consortium (CPP) is a precompetitive collaboration consisting of pharmaceutical industry members, academic experts, advisors, patient organizations, and individuals with PD. The goal is to use regulatory science to aid development of drug development tools under advisement of health regulators worldwide. A team of neuroimaging experts, advisors, and patient advocates collaborate to develop recommendations for neuroimaging biomarkers that can be used with confidence in drug development.
Results: The workgroup has identified relevant neuroimaging biomarkers and determined their specific roles in drug development according to BEST criteria. To evaluate the suitability of each biomarker we are currently developing evidentiary standards. The ultimate goal is to establish consensus recommendations for selected neuroimaging biomarkers so that these can be implemented with confidence in PD drug development.
Conclusion: The main objective of CPP’s precompetitive consortium is to improve the health of individuals with PD in a collaborative manner involving all pertinent stakeholders. The consensus recommendation findings of the neuroimaging workgroup may serve as a guide for both drug developers and clinical researchers. Through precompetitive collaboration and guidance from health regulators, CPP ensures that the identified neuroimaging biomarkers can be used with a high degree of confidence in drug development. This will help facilitate the development of much-needed interventions for individuals with PD.
To cite this abstract in AMA style:
M. Muller, R. Comley, J. Eberling, H. Kazmi, T. Kustermann, P. Maguire, K. Marek, C. Mcginnity, M. Minchik, C. Parker, L. Passamonti, O. Rousset, D. Russell, C. Salinas, J. Seibyl, S. Sivakumaran, J. Stoessl, A. Strafella, D. Tosun-Turgut, Y. Wang, D. Stephenson, G. Pagano. The Critical Path for Parkinson’s Consortium approach to developing consensus recommendations for neuroimaging biomarkers appropriate for use in Parkinson’s disease drug development [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/the-critical-path-for-parkinsons-consortium-approach-to-developing-consensus-recommendations-for-neuroimaging-biomarkers-appropriate-for-use-in-parkinsons-disease-drug-development/. Accessed June 15, 2025.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-critical-path-for-parkinsons-consortium-approach-to-developing-consensus-recommendations-for-neuroimaging-biomarkers-appropriate-for-use-in-parkinsons-disease-drug-development/