Active — Not RecruitingNot Applicable

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

United States100 participantsStarted 2024-12-17

Plain-language 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.

Who can participate

Age range50 Years – 85 Years

SexALL

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Inclusion criteria

✓. Male and female 50 to 85 years of age
✓. Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior

Exclusion criteria

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

What they're measuring

Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months

Timeframe: 18 months

Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months

Timeframe: 18 months

Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months

Timeframe: 18 months

Trial details

NCT IDNCT06621602

SponsorCND Life Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

View on ClinicalTrials.gov More REM Behavior Disorder trials