NCT06621602

Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: CND Life Sciences · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.

Detailed description

This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.

Conditions

• REM Behavior Disorder
• Parkinson Disease

Timeline

• Start date: 2024-12-17
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-10-01
• Last updated: 2026-02-11

Locations

18 sites across 1 country: United States