CND Life Sciences' Syn-One Test® Detects Alpha-Synuclein in Skin Biopsies of Patients with REM Sleep Behavior Disorder

Data from the Syn-Sleep Study shows the Syn-One Test detected phosphorylated alpha-synuclein in skin biopsies of 75% of patients with iRBD at baseline

This NIH-sponsored, multicenter, prospective study is being conducted at 11 sites across the U.S. and involves 80 participants

SCOTTSDALE, Ariz., June 5, 2025 /PRNewswire/ -- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced baseline results from the Syn-Sleep Study, a 24-month longitudinal study funded by the National Institutes of Health (NIH). The study is investigating 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. Results thus far have shown P-SYN detection in 75% of patients with iRBD at baseline.¹

These results and more information will be presented at SLEEP 2025, the 39^th annual meeting of the Associated Professional Sleep Societies, LLC, a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society. This year's event will be held in Seattle, Washington June 8-11 and CND will exhibit in Booth 1444.

iRBD is a sleep disorder that causes affected individuals to act out their dreams, often with violent movements and vocalizations. Individuals with iRBD may kick, punch, jump out of bed, and yell in their sleep. It is considered "idiopathic" when there is no clear cause for the condition's symptoms. iRBD is a well-established early indicator of future neurodegenerative conditions involving P-SYN.² P-SYN is 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). One key scientific paper showed that 73.5% of patients diagnosed with iRBD (n=1,280) converted to PD, DLB, or MSA within 12 years.³

The Syn-One Test measures the presence of intra-neuronal P-SYN through a simple in-office skin punch biopsy procedure and has previously demonstrated 95% positivity rate in patients with clinically definite synucleinopathies including PD, DLB, and MSA.⁴

By using the Syn-One Test, the goals of the Syn-Sleep Study are to assess 1) the presence of P-SYN in skin biopsies in iRBD patients with no evidence of a neurodegenerative disease, and 2) if the pattern of P-SYN deposition is a predictor of future phenoconversion to a clinically definite synucleinopathy.¹

"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."

Summary results:

• A total of 80 patients with iRBD without evidence of other neurodegenerative disease enrolled in the Syn-Sleep Study
• Enrolled subjects had symptoms of iRBD for an average of 6.7 years
• Patients with abnormal test results tended to be older and had the disease for longer periods
• Those individuals with P-SYN found in skin biopsy tended to have a greater degree of hyposmia
• 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)¹

"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."

Poster presentation details are as follows:

About the Syn-Sleep Study
The Syn-Sleep Study investigates the rate of cutaneous phosphorylated alpha-synuclein (P-SYN) deposition in patients with idiopathic REM sleep behavior disorder (iRBD). This NIH-sponsored multicenter, prospective study is being conducted at 11 sites across the U.S. and will assess whether the presence of cutaneous P-SYN is predictive of future phenoconversion to clinically definite synucleinopathy during longitudinal follow up. iRBD has a high risk of phenoconversion to a clinically apparent synucleinopathy (including Parkinson's disease, multiple system atrophy or dementia with Lewy bodies) with 73.5% of patients converting to a clinically apparent synucleinopathy within 12 years.³ Participating Syn-Sleep Study 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. 

About CND Life Sciences
CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose synucleinopathies that include Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder. Syn-One uses proprietary immunofluorescence techniques to detect, visualize, and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a prospective, multicenter, NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) in 2024 demonstrating >95% sensitivity overall in patients with a clinically determined synucleinopathy.⁴ The test analyzes three small skin biopsy samples collected in a clinician's office through an in-office patient procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. More than 3,000 neurologists and other clinicians in 50 states have used the Syn-One Test to support their diagnostic evaluation of patients. The company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting studies assessing the test's ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn.

Media Contact:
Jaryd Leady
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Company Contact:
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SVP, Commercial Strategy & Market Development
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References

1. Levine T, Gibbons CH, Bellaire B, et al. The Syn-Sleep Study: Detection of Cutaneous Phosphorylated Alpha-Synuclein in REM Sleep Behavior Disorder. Abstract.
2. Iranzo A, Santamaria J, Tolosa E. Idiopathic rapid eye movement sleep behaviour disorder: diagnosis, management, and the need for neuroprotective interventions. Lancet Neurol. 2016 Apr;15(4):405-19. doi: 10.1016/S1474-4422(16)00057-0.
3. Postuma RB, Iranzo A, Hu M, et al. Risk and predictors of dementia and parkinsonism in idiopathic REM sleep behaviour disorder: a multicentre study. Brain. 2019;142(3):744-759. doi:10.1093/brain/awz030.
4. 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.

SOURCE CND Life Sciences