Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 试验地点
- 23
- 主要终点
- Primary Outcome 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary Outcome 1
时间窗: 2 years
To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 2
时间窗: 2 years
To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.
Primary Outcome 3
时间窗: 2 years
To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
次要结局
未报告次要终点