Synuclein-One Study

December 29, 2023 updated by: CND Life Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
428

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome 1
Time Frame: 2 years
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
2 years
Primary Outcome 2
Time Frame: 2 years
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
2 years
Primary Outcome 3
Time Frame: 2 years
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CND Life Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd Levine, MD, CND Life Sciences: www.cndlifesciences.com

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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