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Completed

NCT Number: NCT04700722

Synuclein-One Study

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Biopsy

Diagnostic Test

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.

Primary outcomes

  1. Primary Outcome 1

    Time frame: 2 years

    To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.

  2. Primary Outcome 2

    Time frame: 2 years

    To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.

  3. Primary Outcome 3

    Time frame: 2 years

    To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.

Sponsors and collaborators

Lead sponsor

CND Life Sciences

Other

Registry information

Official study title

Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 8, 2021
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.