Synuclein-One Study

Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy

The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Multiple System Atrophy; Pure Autonomic Failure; Dementia With Lewy Bodies
• Intervention / Treatment: Diagnostic test: Skin Biopsy

Detailed Description

Phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. An effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.

• Study Type: Observational
• Enrollment (Actual): 428

Contacts and Locations

• Study Contact: Name: Jade Stohl; Phone Number: 105 480-569-2900; Email: jstohl@cndlifesciences.com
• Study Contact Backup: Name: Todd Levine, MD; Phone Number: 480-569-2900; Email: levine@cndlifesciences.com

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85286
      • MD First Research
    • Phoenix, Arizona, United States, 85018
      • CND Life Sciences
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center of Arizona
  • California
    • Carlsbad, California, United States, 92011
      • The Neuro Center
    • Santa Monica, California, United States, 90404
      • Providence St. John's Health
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Movement Disorders Center, PC
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Neurology
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Gainesville, Florida, United States, 32608
      • UF College of Medicine
    • Port Charlotte, Florida, United States, 33980
      • Parkinson's Disease Treatment Center SWFL
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Lahey Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10016
      • NYU Medical Center
    • Patchogue, New York, United States, 11772
      • SouthShore Neurologic
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Brain & Spine Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UTSouthwestern
    • Georgetown, Texas, United States, 78628
      • Texas Movement Disorders Specialists
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Health
    • Seattle, Washington, United States, 98122
      • Swedish Neuroscience Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Eligible men and women, age 40-99 years, will undergo a screening evaluation that includes a thorough medical history, physical and neurologic exam, orthostatic vitals, questionnaires and skin biopsy completed in one visit.

Description

Inclusion Criteria:

• Male and female between 40-99 years of age
• Prior clinical diagnosis of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure
• Health Subjects, no history of clinical or symptoms suggestive with synucleinopathy

Exclusion Criteria:

• Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication)
• Clinically active coronary artery or cerebrovascular disease
• Current smoker or alcoholism
• History of allergic reaction to local anesthesia for skin biopsies
• Use of blood thinners (aspirin or Plavix alone is allowed)
• Significantly impaired wound healing or history of scarring or keloid formation
• Healthy individuals or individuals with synucleinopathy is disease may be explained by other causes: recent history of encephalitis, Cortical dementia of Alzheimer's type, Whipple's disease, toxin exposure, repeated head injury and stepwise disease progression suggestive of vascular etiology

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease; Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age.	Diagnostic test: Skin Biopsy; Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Multiple System Atrophy; Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age.	Diagnostic test: Skin Biopsy; Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Dementia with Lewy bodies; Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age.	Diagnostic test: Skin Biopsy; Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Pure Autonomic Failure; Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age.	Diagnostic test: Skin Biopsy; Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Healthy Controls; No history of clinical or symptoms suggestive of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure between 40-99 years of age.	Diagnostic test: Skin Biopsy; Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome 1	To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.	2 years
Primary Outcome 2	To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.	2 years
Primary Outcome 3	To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.	2 years

Collaborators and Investigators

• Sponsor: CND Life Sciences
• Investigators: Principal Investigator: Todd Levine, MD, CND Life Sciences: www.cndlifesciences.com

Publications and helpful links

General Publications

• Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neurodegenerative Diseases
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Parkinson Disease; Lewy Body Disease; Multiple System Atrophy; Shy-Drager Syndrome; Pure Autonomic Failure
• Other Study ID Numbers: CND-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared with researchers that are involved in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No