Alpha-synuclein — the protein that clumps in brain cells of people with Parkinson’s — is not only a therapeutic target but also may be a measure of disease. Today, The Michael J. Fox Foundation (MJFF) launched the Systemic Synuclein Sampling Study (S4) to further investigate alpha-synuclein as a potential biomarker of Parkinson’s disease (PD). The study aims to determine if and how alpha-synuclein can be used to diagnose PD, track progression and evaluate the impact of therapies.
A biomarker — such as cholesterol level for heart disease — is a substance or characteristic in the body that helps track the presence or progression of a disease. Currently, there is no identified biomarker of Parkinson’s disease. Such a tool would transform diagnosis and treatment for people living with the disease today by helping to diagnose and intervene earlier and to test whether a potential therapy is altering the course of the disease.
The protein alpha-synuclein is the most promising Parkinson’s biomarker candidate because it’s been shown to clump in the brain cells of nearly all individuals with PD. But it’s also found elsewhere in the body, including saliva, spinal fluid, colon tissue, blood, skin and more. S4 will analyze these tissues and fluids to form a holistic picture of how alpha-synuclein around the body relates to Parkinson's disease.
“Measuring alpha-synuclein levels in these biofluids and tissues could be a way to monitor Parkinson’s disease,” said Danna Jennings, MD, S4 principal investigator and senior director of clinical research at the Institute for Neurodegenerative Disorders. “Multiple studies have demonstrated the significance of alpha-synuclein as a potential PD biomarker, but none have measured alpha-synuclein levels in multiple biofluids and peripheral tissues in a single individual.”
S4 researchers hope to determine which biofluids and tissues are the most promising Parkinson’s biomarker sites. Moreover, the study will help scientists understand which measure of alpha-synuclein outside the brain could be used in clinical trials to assess the effectiveness of new therapies.
“I had symptoms for 10 years before my Parkinson’s diagnosis. Perhaps if we had earlier markers of the disease, I could have started treatment and contributed to research sooner,” said Peter Ortali, an S4 participant at the Institute for Neurodegenerative Disorders. “I believe in doing anything to help others with Parkinson’s. Participating in studies such as S4 will lead to more knowledge and earlier treatments. It's worth the time.”
The study will be carried out at seven sites in the United States and Canada. S4 is enrolling 60 people with Parkinson’s across all stages of the disease and 20 control volunteers. As an observational study, S4 will not test any experimental drug. Participants will contribute to a large collection of data and biological specimens that will be used to further biomarker research.
Visit www.foxtrialfinder.org/S4 to learn more about S4, as well as other clinical trials and research studies recruiting volunteers.
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