Synuclein-One Study
- Conditions
- Dementia With Lewy BodiesParkinson DiseasePure Autonomic FailureMultiple System Atrophy
- Interventions
- Diagnostic Test: Skin Biopsy
- Registration Number
- NCT04700722
- Lead Sponsor
- CND Life Sciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 428
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pure Autonomic Failure Skin Biopsy Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age. Healthy Controls Skin Biopsy 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. Dementia with Lewy bodies Skin Biopsy Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age. Parkinson's disease Skin Biopsy Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age. Multiple System Atrophy Skin Biopsy Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age.
- Primary Outcome Measures
Name Time Method Primary Outcome 1 2 years To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 2 2 years To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 3 2 years To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Rocky Mountain Movement Disorders Center, PC
🇺🇸Englewood, Colorado, United States
Aventura Neurology
🇺🇸Aventura, Florida, United States
Parkinson's Disease Treatment Center SWFL
🇺🇸Port Charlotte, Florida, United States
UTSouthwestern
🇺🇸Dallas, Texas, United States
Swedish Neuroscience Research
🇺🇸Seattle, Washington, United States
NYU Medical Center
🇺🇸New York, New York, United States
Movement Disorders Center of Arizona
🇺🇸Scottsdale, Arizona, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Lahey Health
🇺🇸Boston, Massachusetts, United States
MD First Research
🇺🇸Chandler, Arizona, United States
The Neuro Center
🇺🇸Carlsbad, California, United States
Evergreen Health
🇺🇸Kirkland, Washington, United States
Providence St. John's Health
🇺🇸Santa Monica, California, United States
Texas Movement Disorders Specialists
🇺🇸Georgetown, Texas, United States
SouthShore Neurologic
🇺🇸Patchogue, New York, United States
UF College of Medicine
🇺🇸Gainesville, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
CND Life Sciences
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Providence Brain & Spine Institute
🇺🇸Portland, Oregon, United States