Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 428
- Locations
- 23
- Primary Endpoint
- Primary Outcome 1
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary Outcome 1
Time Frame: 2 years
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 2
Time Frame: 2 years
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 3
Time Frame: 2 years
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Secondary Outcomes
No secondary outcomes reported