Effective treatments to halt or delay progression of Parkinson’s disease (PD) are lacking and urgently needed.  Progress in clinical development could be hastened by clearer understanding of aspects of health and disease that are important to patients and their families.  This promise has led to a global urgency to define and quantify meaningfulness and meaningful benefits aligned with regulatory requirements necessary for patient-centered drug development. 

While substantial work has been invested to identify meaningful symptoms and impacts in PD, there is no widely accepted symptom framework to support selection of key concepts of interest (i.e., symptoms, impacts of disease) in general or by disease-stage. 

A multi-stakeholder task force including academic researchers and clinician scientists, industry, nonprofits, regulators, and people affected by PD has developed a data-driven Consensus Conceptual Model for Early Parkinson’s Disease. The model is a first step toward aligning the field on concepts of interest in early clinical PD (less than 3 years from diagnosis) to enable improved, patient-centric tool development. It was designed to be flexible with the expectation of refinement over time through iterative reevaluation as the field moves towards a more unified approach towards biological staging and identification of stage-based concepts of interests.  

Committed to understanding and amplifying the voice of the patient, this multi-stakeholder task force under the Critical Path for Parkinson’s has come together to review data and literature and to develop a conceptual model that is ready for broad field input:  

• Jamie Adams, University of Rochester 

• Claire Bale, Parkinson’s UK 

• Evan Davies, F. Hoffman-La Roche 

• Katie Kopil, The Michael J. Fox Foundation for Parkinson’s Research 

• Jennifer Mammen, University of Massachusetts, Dartmouth 

• Rikki Mangrum, Vector Psychometric Group 

• Connie Marras, University of Toronto 

• Tiago Mestre, University of Ottawa 

• Thomas Morel, UCB 

• Chris Redmond, Parkinson’s Research Advocate 

• Tanya Simuni, Northwestern University Feinberg School of Medicine 

• Glenn Stebbins, Rush University 

• Diane Stephenson, Critical Path for Parkinson’s, Critical Path Institute 

• Mirinda Tyo, University of Massachusetts, Dartmouth 

• Yuge Xiao, The Michael J. Fox Foundation for Parkinson’s Research 

• Community Advisory Group (comprised of 9 people affected by PD) 

Together, we are putting forward the Consensus Conceptual Model of Early Parkinson’s Disease for comment ahead of submission for publication to raise awareness of this emerging tool for clinical development and to build alignment toward broad consensus on meaningfulness in early PD   across the field.   

We invite you to contribute your perspectives to this effort by reviewing and providing comments by Monday, February 26.