Biomarkers — a biological marker of disease presence or risk like cholesterol level for heart disease — will greatly aid clinicians’ ability to diagnose Parkinson’s disease (PD), predict its progression, identify at-risk individuals and monitor therapeutic efficacy. Unfortunately, no reliable, quantitative or validated biomarker for PD currently exists. The majority of previous PD biomarker studies have been limited by small sample size, inclusion of different patient populations and lack of independent validation.
To address this critical gap in biomarker research, The Michael J. Fox Foundation (MJFF), with support from the National Institute of Neurological Disorders and Stroke (NINDS), launched The Fox Investigation for New Discovery of Biomarkers (BioFIND). BioFIND is an observational, cross-sectional, multi-center study of biomarkers in moderate to advanced PD and control subjects. Clinical data and samples acquired from study participants will be made available to researchers to discover novel PD biomarkers and validate their initial findings in a well-characterized PD cohort.
The BioFIND study aims to complement the Parkinson’s Progression Marker Initiative (PPMI) to provide a platform for discovery and validation in moderate to advanced stage PD. The longitudinal PPMI study provides a resource for early PD to investigate progression biomarkers. Combined, these resources provide the most comprehensive and long-ranging dataset available for PD biomarker research.
BioFIND is collecting cross-sectional clinical data and biospecimens — including plasma, DNA and RNA from blood, whole blood, blood pellet, and cerebrospinal fluid — in a population of 120 clinically typical, moderate to advanced PD and 120 control subjects.
BioFIND will follow standardized data acquisition protocols to ensure that tests and assessments conducted at multiple sites can be pooled. Data and samples acquired from study participants will enable the development of a comprehensive Parkinson's database and biorepository, which will be available to the scientific community.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
The identification of biomarkers to diagnose and correlate with PD severity would greatly improve the clinical treatment and development of new therapies for Parkinson’s patients.
The motivation behind providing access to BioFIND data and biospecimens is to promote the discovery of biomarkers for PD diagnosis and disease severity. The biospecimens, paired with the clinical data, from the well-defined PD patient population in BioFIND serve as valuable resources for the eventual goals of:
- Discovery of novel biomarkers for PD diagnosis
- Identification and characterization of PD-specific alterations in biologic specimens from a well-defined PD cohort
- Development of predictive tools for PD subtype stratification, including disease severity
- Identification of biomarker candidates to test their utility as progression markers in the PPMI study and to assist in future clinical drug trials and therapeutic target monitoring