Measuring a protein in skin biopsies to track Parkinson's disease
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
This study is testing if measuring a specific protein in skin samples can help track how Parkinson's disease and REM Behavior Disorder progress in patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | CND Life Sciences Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06621602 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify phosphorylated alpha-synuclein (P-SYN) levels in skin biopsies from patients diagnosed with Parkinson's disease and REM Behavior Disorder. It will involve 100 participants, with evaluations conducted at baseline and every six months for 18 months to monitor disease progression. The study seeks to establish P-SYN as a potential biomarker for tracking the natural progression of these conditions through minimally invasive procedures.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50 to 100 with a confirmed diagnosis of Parkinson's disease or REM Behavior Disorder.
Not a fit: Patients with severe vascular disease, impaired wound healing, or allergic reactions to local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for monitoring disease progression in Parkinson's disease and REM Behavior Disorder.
How similar studies have performed: While the approach of using skin biopsies for biomarker quantification is promising, it remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona
- CND Life Sciences — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Todd Levine — CND Life Sciences
- Study coordinator: Clinical Research
- Email: clinicalresearch@cndlifesciences.com
- Phone: 480-569-2902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.