Parkinson Disease Clinical Trial
Official title:
Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
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 |
Verified date | December 2023 |
Source | CND Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CND Life Sciences |
United States,
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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