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

Recruiting

• Conditions: REM Behavior Disorder; Parkinson Disease

• Registration Number: NCT06621602
• Lead Sponsor: CND Life Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-28
• Study First Posted: 2024-10-01
• Study Start: 2024-12-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male and female 50 to 100 years of age
2. Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months	18 months	The sensitivity of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months Time Frame: 18 months

Trial Locations

Locations (13)

Movement Disorders Center of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Parkinson's Research Centers of America - Orange County; 🇺🇸 Aliso Viejo, California, United States

Cedars Sinai; 🇺🇸 Los Angeles, California, United States

Parkinson's Research Centers of America - Palo Alto; 🇺🇸 Palo Alto, California, United States

Aventura Neurologic Associates, LLC; 🇺🇸 Aventura, Florida, United States

Parkinson's Disease and Movement Disorders Center - Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Atlanta NeuroScience Institute ANI; 🇺🇸 Atlanta, Georgia, United States

Parkinson's Disease and Movement Disorders Center at KUMC; 🇺🇸 Kansas City, Kansas, United States

Neurology Multidisciplinary Clinic at Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

Boston Neuro Research Center; 🇺🇸 Boston, Massachusetts, United States

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