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

February 9, 2026 updated by: CND Life Sciences
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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Movement Disorders Center of Arizona
      • Scottsdale, Arizona, United States, 85258
        • CND Life Sciences
    • California
      • Aliso Viejo, California, United States, 92656
        • Parkinson's Research Centers of America - Orange County
      • Los Angeles, California, United States, 90048
        • Cedars Sinai
      • Palo Alto, California, United States, 94301
        • Parkinson's Research Centers of America - Palo Alto
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Neurologic Associates, LLC
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center - Boca Raton
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Atlanta NeuroScience Institute ANI
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Parkinson's Disease and Movement Disorders Center at KUMC
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Neurology Multidisciplinary Clinic at Norton Healthcare
    • Maryland
      • Olney, Maryland, United States, 20832
        • MedStar Montgomery Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02747
        • Boston Neuro Research Center
    • New York
      • Commack, New York, United States, 11725
        • Parkinson's Research Centers of America - Long Island
      • Rochester, New York, United States, 14618
        • University of Rochester
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • The Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38157
        • Veracity Neuroscience LLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from 18 sites across the US from academic institutions and private clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CND Life Sciences

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Todd Levine, CND Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJFF-025208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe