CND Life Sciences reported baseline results from its NIH-sponsored Syn-Sleep Study, demonstrating the Syn-One Test’s ability to detect phosphorylated alpha-synuclein (P-SYN) in 75% of patients with idiopathic REM sleep behavior disorder (iRBD). The 24-month longitudinal study enrolled 80 participants across 11 US sites, representing a critical validation step for cutaneous biomarker detection in prodromal neurodegenerative disease.
The study’s design addresses a significant diagnostic gap in synucleinopathy management. iRBD patients face a 73.5% risk of converting to Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy within 12 years, yet current diagnostic approaches rely on clinical manifestation rather than molecular detection. The Syn-One Test’s minimally invasive skin biopsy procedure offers a potential solution, having previously demonstrated 95% sensitivity in clinically confirmed synucleinopathies across over 3,000 neurologist users nationwide.
Baseline data revealed meaningful clinical correlations: patients with positive P-SYN detection were older, had longer symptom duration, averaging 6.7 years, and exhibited greater hyposmia severity. Notably, P-SYN positivity rates remained consistent regardless of iRBD symptom severity or diagnostic method, suggesting robust biomarker reliability across patient populations.
“The ability to detect those patients at risk opens the door for earlier disease modulation and prevention trials,” stated Dr. Todd Levine, CND’s Chief Medical Officer and principal investigator. This capability addresses pharmaceutical companies’ growing need for enriched patient populations in neuroprotective drug development, where traditional recruitment methods often capture patients too late in disease progression.
