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

NCT ID: NCT06621602

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-17

Study Completion Date

2027-04-30

Brief Summary

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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

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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

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REM Behavior Disorder Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

CND Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Levine

Role: PRINCIPAL_INVESTIGATOR

CND Life Sciences

Locations

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CND Life Sciences

Scottsdale, Arizona, United States

Site Status

Movement Disorders Center of Arizona

Scottsdale, Arizona, United States

Site Status

Parkinson's Research Centers of America - Orange County

Aliso Viejo, California, United States

Site Status

Cedars Sinai

Los Angeles, California, United States

Site Status

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Aventura Neurologic Associates, LLC

Aventura, Florida, United States

Site Status

Parkinson's Disease and Movement Disorders Center - Boca Raton

Boca Raton, Florida, United States

Site Status

Atlanta NeuroScience Institute ANI

Atlanta, Georgia, United States

Site Status

Parkinson's Disease and Movement Disorders Center at KUMC

Kansas City, Kansas, United States

Site Status

Neurology Multidisciplinary Clinic at Norton Healthcare

Louisville, Kentucky, United States

Site Status

MedStar Montgomery Medical Center

Olney, Maryland, United States

Site Status

Boston Neuro Research Center

Boston, Massachusetts, United States

Site Status

Parkinson's Research Centers of America - Long Island

Commack, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

The Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Veracity Neuroscience LLC

Memphis, Tennessee, United States

Site Status

UT Health San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Gibbons CH, Levine T, Adler C, Bellaire B, Wang N, Stohl J, Agarwal P, Aldridge GM, Barboi A, Evidente VGH, Galasko D, Geschwind MD, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis M, Reynolds A, Sahagian GA, Saint-Hillaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Yerstein O, Freeman R. Skin Biopsy Detection of Phosphorylated alpha-Synuclein in Patients With Synucleinopathies. JAMA. 2024 Apr 16;331(15):1298-1306. doi: 10.1001/jama.2024.0792.

Reference Type RESULT
PMID: 38506839 (View on PubMed)

Other Identifiers

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MJFF-025208

Identifier Type: -

Identifier Source: org_study_id

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