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

Last updated: February 9, 2026
Sponsor: CND Life Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

N/A

Clinical Study ID

NCT06621602
MJFF-025208
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female 50 to 85 years of age

  2. Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior

Exclusion

Exclusion Criteria:

  1. Clinical evidence of severe vascular disease (history of ulceration, poor woundhealing or vascular claudication)

  2. History of allergic reaction to Lidocaine for local anesthesia needed for skinbiopsies

  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

Total Participants: 100
Study Start date:
December 17, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • CND Life Sciences

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • CND Life Sciences

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • Movement Disorders Center of Arizona

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Orange County

    Aliso Viejo, California 92656
    United States

    Site Not Available

  • Cedars Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California 94301
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Orange County

    Aliso Viejo 5323163, California 5332921 92656
    United States

    Site Not Available

  • Cedars Sinai

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto 5380748, California 5332921 94301
    United States

    Site Not Available

  • University of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Aventura Neurologic Associates, LLC

    Aventura, Florida 33180
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center - Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Aventura Neurologic Associates, LLC

    Aventura 4146429, Florida 4155751 33180
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center - Boca Raton

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • Atlanta NeuroScience Institute ANI

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Atlanta NeuroScience Institute ANI

    Atlanta 4180439, Georgia 4197000 30327
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center at KUMC

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center at KUMC

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Neurology Multidisciplinary Clinic at Norton Healthcare

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Neurology Multidisciplinary Clinic at Norton Healthcare

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Site Not Available

  • MedStar Montgomery Medical Center

    Olney 4364537, Maryland 4361885 20832
    United States

    Site Not Available

  • Boston Neuro Research Center

    Boston, Massachusetts 02747
    United States

    Site Not Available

  • Boston Neuro Research Center

    Boston 4930956, Massachusetts 6254926 02747
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Long Island

    Commack, New York 11725
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Long Island

    Commack 5113412, New York 5128638 11725
    United States

    Site Not Available

  • University of Rochester

    Rochester 5134086, New York 5128638 14618
    United States

    Site Not Available

  • The Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29403
    United States

    Site Not Available

  • Veracity Neuroscience LLC

    Memphis, Tennessee 38157
    United States

    Site Not Available

  • Veracity Neuroscience LLC

    Memphis 4641239, Tennessee 4662168 38157
    United States

    Site Not Available

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UT Health San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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