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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04700722
Other study ID # CND-100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date November 8, 2023

Study information

Verified date December 2023
Source CND Life Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 428
Est. completion date November 8, 2023
Est. primary completion date December 14, 2022
Accepts healthy volunteers
Gender All
Age group 40 Years to 99 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated a-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated a-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated a-synuclein with skin biopsies.

Locations

Country Name City State
United States Aventura Neurology Aventura Florida
United States Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida
United States Beth Israel Lahey Health Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States The Neuro Center Carlsbad California
United States MD First Research Chandler Arizona
United States UTSouthwestern Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Rocky Mountain Movement Disorders Center, PC Englewood Colorado
United States NorthShore University Health System Evanston Illinois
United States UF College of Medicine Gainesville Florida
United States Texas Movement Disorders Specialists Georgetown Texas
United States Evergreen Health Kirkland Washington
United States Vanderbilt University Medical Center Nashville Tennessee
United States NYU Medical Center New York New York
United States SouthShore Neurologic Patchogue New York
United States CND Life Sciences Phoenix Arizona
United States Parkinson's Disease Treatment Center SWFL Port Charlotte Florida
United States Providence Brain & Spine Institute Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Providence St. John's Health Santa Monica California
United States Movement Disorders Center of Arizona Scottsdale Arizona
United States Swedish Neuroscience Research Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
CND Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

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