The Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a $4.2 million grant to CND Life Sciences to further investigate a skin test for the diagnosis and progression tracking of Parkinson's disease. The grant will support the Syn-Q clinical trial, which focuses on the Syn-One Test, a method for quantifying phosphorylated alpha-synuclein in skin samples. Alpha-synuclein is a protein known to form clumps in individuals with Parkinson's disease. This initiative aims to enhance early diagnosis and treatment strategies for the debilitating neurodegenerative disorder.
Syn-Q Clinical Trial Details
The Syn-Q trial will evaluate the Syn-One Test's ability to measure phosphorylated alpha-synuclein levels in skin nerve fibers. Previous research, including the NIH-sponsored Synuclein-One Study (NCT04700722), indicated that the Syn-One Test correctly identified 95% of patients with synucleinopathy and 92.7% of those suspected of having Parkinson's disease. The Syn-Q trial seeks to build upon these findings by monitoring alpha-synuclein progression over time.
The trial is set to enroll 75 Parkinson's patients and 25 individuals with REM Sleep Behavior Disorder, a condition often linked to Parkinson's. The study will involve approximately 25 clinical centers to ensure participant diversity.
Significance of Alpha-Synuclein in Parkinson's
Parkinson's disease is characterized by the progressive loss of dopaminergic neurons, which are crucial for producing dopamine, a neurotransmitter essential for motor control. A key pathological feature of Parkinson's is the formation of Lewy bodies, abnormal protein clumps primarily composed of phosphorylated alpha-synuclein. These clumps contribute to neuronal damage and subsequent motor and cognitive impairments.
Expert Perspectives
"This grant from MJFF will accelerate our efforts to quantify and monitor alpha-synuclein progression over time," said Todd Levine, MD, chief medical officer at CND. Mark Frasier, PhD, MJFF's chief scientific officer, emphasized the importance of biomarkers, stating, "Biomarkers are critical to early diagnosis and the development of effective treatments for Parkinson’s disease. The Foundation supports an aggressive agenda to develop quantitative biomarkers of progression that enables research and improves clinical trials."
Addressing Diagnostic Challenges
Early and accurate diagnosis of Parkinson's disease is crucial for timely access to neurological care. However, a significant proportion of Parkinson's patients are misdiagnosed, particularly in the early stages. Traditional diagnostic methods, such as cerebrospinal fluid collection, can be highly invasive. The Syn-One Test offers a less invasive alternative by using skin biopsies to assess phosphorylated alpha-synuclein levels.
Future Implications
"We believe this study will provide a foundational understanding of the natural progression of phosphorylated alpha-synuclein deposition in Parkinson’s disease patients and support the ability to recognize who responds to treatment, assess therapeutic impact, and monitor disease progression," said Christopher Gibbons, MD, chief scientific officer at CND. While the Syn-One Test is highly specific for synucleinopathy, CND recommends that results be interpreted in conjunction with other clinical findings for a more precise diagnosis.
