NEW YORK (March 16, 2016) — The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has launched the observational Systemic Synuclein Sampling Study (S4) to investigate the protein alpha-synuclein as a biomarker of Parkinson’s disease (PD). The study aims to determine in which biofluids and tissues researchers should measure alpha-synuclein to diagnose PD, track progression and evaluate the impact of therapies with the potential to slow or stop disease progression.
Currently, there is no definitive, objective biomarker or test to diagnose PD and follow its progression in a living individual. A PD biomarker — a substance or characteristic in the body associated with disease presence or that changes over time in a way that can be linked to progression — would revolutionize not only clinical care but also research.
“A Parkinson’s biomarker would allow researchers to better understand the disease process and to develop and test treatments that may slow or stop progression,” said Mark Frasier, senior vice president of research programs at MJFF. “Such a tool would also confirm people in PD studies have not been misdiagnosed and have Parkinson’s pathology, so therapies with true potential aren’t eliminated due to false negatives.”
The protein alpha-synuclein is the most promising Parkinson’s biomarker candidate as it has been shown to aggregate in the brain cells of individuals with PD. Alpha-synuclein is also measurable in bodily fluids and tissues outside the brain — including cerebrospinal fluid, blood, skin, colon tissue, saliva and submandibular gland tissue.
“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.”
By comprehensively studying both intrapersonal and interpersonal alpha-synuclein variability, researchers hope to determine which biofluids and tissues are the most promising Parkinson’s biomarker sites. Moreover, S4 will help researchers understand which measure of alpha-synuclein outside the brain could be used in clinical trials to assess efficacy of therapies with disease-modifying potential.
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.
Upon completion of the study, data and biospecimens will be de-identified and made available to the research community.
Individuals can visit www.foxtrialfinder.org/S4 to learn more about S4, as well as other clinical trials and research studies recruiting volunteers.