The methodology behind the Synuclein-One Study, the largest study to date of cutaneous phosphorylated alpha-synuclein detection, was published this month in Biomarkers in Medicine by CND Life Sciences’ senior scientific advisors Dr. Christopher Gibbons and Dr. Roy Freeman and members of CND’s scientific team, Todd Levine, MD and Bailey Bellaire.
The objective of the NIH-funded Synuclein-One Study is to advance the diagnostic utility of immunofluorescence detection of phosphorylated alpha-synuclein in clinically definite synucleinopathies.
The synucleinopathies encompass a group of neurological disorders that includes Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. The primary outcome of the study is the sensitivity and specificity of the Syn-One Test®, which uses small 3-mm skin punch biopsies and a proprietary immunofluorescence technique. A secondary objective is using the Syn-One Test to help clinicians distinguish between the different synucleinopathies.
The multi-center observational study will recruit 300 patients with clinically definite synucleinopathies and 100 healthy controls. Blinded biopsy results will be read by two independent laboratories and blinded clinical data will be evaluated by two independent disease experts.
The study authors note that a simple, reliable, minimally invasive method for detecting synuclein pathology is essential to patient care, and the need for such a diagnostic tool continues to grow as the US population ages. Further, diagnostic accuracy is fundamental to clinical trial inclusion criteria when evaluating potentially disease-modifying treatments. Therefore, the need for a large-scale and methodologically sound investigation of phosphorylated alpha-synuclein detection has never been greater.
