CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, has officially announced baseline results from its Syn-Sleep Study, which happens to be a 24-month longitudinal exercise, funded by the National Institutes of Health (NIH).
According to certain reports, the stated study is structured to investigate deposition of phosphorylated alpha-synuclein (P-SYN) in skin biopsies of patients with both idiopathic REM sleep behavior disorder (iRBD) and no evidence of other neurodegenerative diseases.
As for the results, they have, thus far, revealed P-SYN detection in 75% of patients with iRBD at baseline. More on that would reveal how these results and more information is slated for presentation at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies, LLC, a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.
Before we dig any further, we must take into account how iRBD is essentially a sleep disorder, which causes affected individuals to act out their dreams, often with violent movements and vocalizations. For instance, individuals suffering from iRBD may kick, punch, jump out of bed, and yell in their sleep.
iRBD is also a well-established early indicator of future neurodegenerative conditions made up with P-SYN which, on its part, would be a pathological protein associated with neurodegenerative conditions known as synucleinopathies, such as Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). In fact, one specific scientific paper showed that 73.5% of patients diagnosed with iRBD (n=1,280) converted to PD, DLB, or MSA within 12 years.
“We are currently doing a longitudinal reassessment of these subjects to determine if quantification of P-SYN can serve as a biomarker of disease progression,” said Todd Levine, MD, chief medical officer of CND Life Sciences, CME, clinical professor at Arizona State University, and the principal investigator of the study. “The ability to detect those patients at risk opens the door for earlier disease modulation and prevention trials.”
Talk about the given study on a slightly deeper level, we ought to mention how it measures the presence of intra-neuronal P-SYN through a simple in-office skin punch biopsy procedure. To understand the significance in play here, it must be acknowledged that the same procedure has previously demonstrated 95% positivity rate among patients with clinically definite synucleinopathies including PD, DLB, and MSA.
Anyway, the primary objective of CND’s study has been assessing the presence of P-SYN in skin biopsies in iRBD patients with no evidence of a neurodegenerative disease, and if the pattern of P-SYN deposition is a predictor of future phenoconversion to a clinically definite synucleinopathy.
Taking a closer look at the results, they effectively reveal that all 80 enrolled subjects had symptoms of iRBD for an average of 6.7 years.
Furthermore, patients who had abnormal test results were found to be older and had the disease for longer periods.
Another detail worth a mention is rooted in a piece of detail claiming that individuals with P-SYN, found in skin biopsy, had a greater degree of hyposmia. Beyond that, during the course of this study, P-SYN positivity rates did not differ based on the severity of iRBD symptoms, autonomic symptoms, or how iRBD was diagnosed (polysomnography or iRBD questionnaire).
Among other things, we ought to mention how Syn-Sleep Study is actually being conducted at 11 sites across the U.S. The participating sites include Banner Health, Cedars-Sinai, Intrepid Research, Kentucky Neuroscience Institute, Lehigh Valley, MD First Research, Movement Disorder Center of Arizona, Stanford University, Mt. Sinai, Texas Institute for Neurological Disorders, and University of Minnesota.
“These results support evidence that iRBD is a prodromal neurodegenerative condition and suggests that a minimally invasive skin biopsy can be used to assess P-SYN status in these patients,” said Michele Tagliati, MD, a movement specialist in the Department of Neurology at Cedars-Sinai in Los Angeles, California and one of the study’s investigators. “As the field advances and there are lifestyle interventions and future drug therapies that could address diseases like PD and DLB before they fully develop, determining if an RBD patient has synuclein deposition will be increasingly important.”
