Study Rationale: We present an unbiased method for biomarker development by analyzing multiple clinical, genomic, molecular, and imaging biomarkers at four time points: baseline, 1-year, 2-year, and an optional 7.5-year follow-up, in a cohort of 517 Parkinson’s disease patients and a cohort of 102 de novo (i.e., unmedicated) Parkinson’s disease patients. Additionally, various physiological measures are included to assess disease progression, including Holter ECG monitoring, to investigate the potential of these physiological markers in understanding and tracking disease impact.
Hypothesis: Which known biomarkers are linked to Parkinson’s disease progression, therapy response, and survival, and how much does each biomarker contribute to predictive models compared to other important factors like clinical measurements and patient assessments?
Study Design: This is a study following 517 people with Parkinson’s disease and 102 de novo Parkinson’s disease patients over a long period of time to collect detailed clinical data as well as diverse biospecimens. During part of the study, participants wore a dedicated study watch that recorded their movement, heart rate, skin temperature, and other data every day, even when they were not at the clinic. These data give more insight on how the disease changes over time. The collected data will be shared with researchers worldwide to help develop better treatments and personalized care.
Impact on Diagnosis/Treatment of Parkinson’s disease: This observational study will follow participants over time while they continue their regular treatment, which is decided by their own doctors. Taking part in the study and the study’s results will not affect how doctors treat the patients.
Next Steps for Development: The study aims to build a large, detailed dataset, including information on genetics, health, and Parkinson’s disease symptoms over time. This data will be shared with approved researchers worldwide, ensuring privacy of the participants and data security, to help answer important questions about Parkinson’s disease and improve disease understanding and treatment.