NCT05757206

The Syn-Sleep Study

Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: CND Life Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• REM Sleep Behavior Disorder (iRBD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Syn-One Test	Participating subjects will have three small skin punch biopsies.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-12-17
• Completion: 2025-12-31
• First posted: 2023-03-07
• Last updated: 2025-01-15

Locations

8 sites across 1 country: United States