CND Life Sciences is conducting a clinical research study to learn more about the progression of Parkinson’s disease (PD). This study is designed to detect the level of phosphorylated alpha-synuclein (P-SYN) in the skin over time and across a spectrum of patients at different stages of severity of PD. P-SYN is a biomarker that has shown promise as an indicator of disease progression.1
CND developed the Syn-One Test® to detect an abnormal protein—phosphorylated alpha-synuclein (P-SYN)—in nerve fibers in the skin. The presence of P-SYN is evidence that a patient has a synucleinopathy, which is a neurodegenerative disease characterized by the accumulation of alpha-synuclein in neurons and glia cells, leading to neural dysfunction and degeneration. Synucleinopathies are a family of neurodegenerative disorders that includes Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure. A fifth condition, REM sleep behavior disorder (RBD), is an early indicator of a synucleinopathy.
Total P-SYN, as detected by skin biopsy correlated with multiple measures of severity in a recently published multi-center cross-sectional study of 428 participants with clinically defined synucleinopathy.1 In this new multicenter study, CND, supported by a grant from the Michael J. Fox Foundation, will work with researchers across the country to further evaluate the correlation between P-SYN and the severity of PD by measuring deposits of P-SYN in the skin longitudinally in RBD patients and PD patients with varying severity. Patients with PD or RBD will have skin samples collected three times over an 18-month period. “Our hope is that if we can show that we can accurately quantify the amount of the protein over time, we will have an objective measure for how the disease progresses,” said Todd Levine, MD, Chief Medical Officer of CND.
The study comes at a critical time as many pharmaceutical companies are developing potential medications to target the accumulation of P-SYN. “The Syn-One Test may be an effective way to measure changes in the levels of P-SYN, and by proxy, the efficacy of these treatments,” said Dr. Levine.
1 Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
