Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
Syn-Q
1 other identifier
observational
100
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
December 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedFebruary 11, 2026
February 1, 2026
1.3 years
September 23, 2024
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
The accuracy 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 .
18 months
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
The precision 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
18 months
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 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
18 months
Eligibility Criteria
Subjects will be enrolled from 18 sites across the US from academic institutions and private clinics.
You may qualify if:
- Male and female 50 to 85 years of age
- Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CND Life Sciences
Scottsdale, Arizona, 85258, United States
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258, United States
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, 92656, United States
Cedars Sinai
Los Angeles, California, 90048, United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301, United States
University of Colorado
Aurora, Colorado, 80045, United States
Aventura Neurologic Associates, LLC
Aventura, Florida, 33180, United States
Parkinson's Disease and Movement Disorders Center - Boca Raton
Boca Raton, Florida, 33486, United States
Atlanta NeuroScience Institute ANI
Atlanta, Georgia, 30327, United States
Parkinson's Disease and Movement Disorders Center at KUMC
Kansas City, Kansas, 66160, United States
Neurology Multidisciplinary Clinic at Norton Healthcare
Louisville, Kentucky, 40241, United States
MedStar Montgomery Medical Center
Olney, Maryland, 20832, United States
Boston Neuro Research Center
Boston, Massachusetts, 02747, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, 11725, United States
University of Rochester
Rochester, New York, 14618, United States
The Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Veracity Neuroscience LLC
Memphis, Tennessee, 38157, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 38506839RESULT
Biospecimen
Tissue of the skin that is collected from three locations using a skin punch biopsy.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Levine
CND Life Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
October 1, 2024
Study Start
December 17, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
February 11, 2026
Record last verified: 2026-02