The Syn-Sleep Study

Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies

In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy.

Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.

Study Overview

• Status: Active, not recruiting
• Conditions: REM Sleep Behavior Disorder (iRBD)
• Intervention / Treatment: Diagnostic test: Syn-One Test

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85286
      • MD First Research
    • Phoenix, Arizona, United States, 85006
      • Banner Health
    • Scottsdale, Arizona, United States, 85258
      • CND Life Sciences
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai
  • Texas
    • Sherman, Texas, United States, 75092
      • Texas Institute for Neurological Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

80 subjects diagnosed with iRBD

Description

Inclusion Criteria:

1. Males and females age 18-85
2. Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
3. Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
4. Polysomnographic recording is consistent with REM sleep without atonia

Exclusion Criteria:

1. Subjects with MoCA < 19, Hoehn and Yahr score >/=1, contraindications to skin biopsy
2. Diagnosis of Parkinson's disease
3. Diagnosis of dementia of any type
4. Diagnosis of multiple system atrophy
5. REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)

6. Contra-indications to skin biopsy:

   1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)
   2. History of allergic reaction to local anesthesia for skin biopsies
   3. Use of blood thinners (aspirin of Plavix alone is allowed)
   4. Significantly impaired wound healing or history of scarring or keloid formation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advance the diagnostic utility of the Syn-One Test	Advance the diagnostic utility of the Syn-One Test™ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients.	3 years
Enhance pathological reading through digital quantitative analysis of the Syn-One Test	Enhance pathological reading through digital quantitative analysis of the Syn-One Test™ using an AI-augmented detection system. Whole slide imaging with extraction of representative neural structures, target stain detection, segmentation, stain quantification and pattern recognition will be performed using deep learning algorithms. Results will be compared against pathologist readings and actual follow-up data to further refine model accuracy.	3 years

Collaborators and Investigators

• Sponsor: CND Life Sciences
• Investigators: Principal Investigator: Todd Levine, CND Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): December 17, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Mental Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: 102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No