Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.
研究概览
简要总结
The primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls.
详细描述
Oxidative stress has been implicated as a factor in the pathogenesis of Parkinson's disease (PD). The overall goal of this proposal is to use a novel metabolomics platform, based on near infrared biospectroscopy, to detect oxidatively modified blood plasma constituents. These spectral findings can be used to model the degree of oxidative stress with a modeled "stress index" that may distinguish PD cases from healthy elderly controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 46 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PD Subjects:
- •PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
- •Willing and able to provide informed consent.
- •Healthy Controls:
- •No current diagnosis or known history of a neurological disease/disorder.
- •Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
- •No first degree relatives with diagnosis of PD
- •MoCA score >
- •Willing and able to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.
时间窗: Baseline and annually for two years
次要结局
- Determine impact of disease stage, age, gender, medications, cognitive scores, other laboratory measures (e.g. alpha-synuclein) and other clinical/demographic variables on plasma biospectra.(Baseline and annually for two years)
- Correlate plasma biospectra with dopamine transporter neuroimaging data.(Baseline and annually for two years)