SYSTEMIC SYNUCLEIN SAMPLING STUDY (S4)
The Systemic Synuclein Sampling Study (S4) is an observational clinical study to better understand the progression of Parkinsonís disease (PD) by identifying the best biofluids and tissues for measuring the protein alpha-synuclein outside of the brain as a potential biomarker in people with PD.
S4 will enroll individuals with Parkinsonís disease and control volunteers across seven clinical sites in the United States and Canada. The study is sponsored by The Michael J. Fox Foundation.
In parallel to its role as a key target for therapeutic development, alpha-synuclein is a promising Parkinsonís disease biomarker. By tracking changes in alpha-synuclein levels in biofluids and tissues Ė cerebrospinal fluid, blood, skin, colon tissue, saliva and submandibular gland tissue Ė we may be able to diagnosis and monitor progression of Parkinsonís disease and measure the impact of interventions.
Multiple studies have shown differences in alpha-synuclein levels of Parkinsonís patients and control volunteers across these biofluids and tissues. However, researchers have never before analyzed one individualís alpha-synuclein levels in each of these biospecimens. By comprehensively studying intra and interpersonal variability, S4 seeks to determine which biofluids and tissues are most promising as Parkinsonís biomarker sites.
S4 is enrolling 60 people with Parkinsonís across all stages of the disease and 20 control volunteers. Unlike other MJFF-sponsored observational studies, the data and biospecimens collected throughout S4 will not be made available to the broader research community while the study is in progress. Because S4 is such a small and novel study, the S4 Steering Committee will conduct the primary analyses of the biofluids and tissues using the most current and effective methods available. All clinical data and remaining biospecimens will be de-identified and made available to the research community after primary analyses of biofluids and tissues are complete.