NCT03545425已完成不适用
FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens
Michael J. Fox Foundation for Parkinson's Research5 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2018年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs
研究概览
简要总结
The overall objective of this study is to determine whether LRRK2 kinase activity and/or mitochondrial DNA (mtDNA) damage could serve as potential biomarkers in PD.
详细描述
Primary Objectives:
- Assess the levels of phosphorylated LRRK2 and LRRK2-phosphorylated Rabs, as measures of LRRK2 kinase activity, in PBMCs and neutrophils from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
- Assess the levels of mtDNA damage in buffy coat from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
- Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
Secondary Objectives:
- To assess the ability of the network to efficiently conduct a study involving biosample collection for PD research. Efficiency will be assessed using measures of the time taken to meet specific milestones within the study.
- To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon, standardized protocols
- To gauge the willingness of participants to participate in subsequent Fox BioNet studies
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LRRK2 Parkinson Disease (PD) Subjects:
- •Patients must have confirmed LRRK2 mutation
- •Patients must meet the MDS criteria for Parkinson's disease
- •Disease duration: any
- •Male or female age 30 years or older at time of PD diagnosis.
- •Idiopathic PD Subjects:
- •Patients must meet the MDS criteria for Parkinson's disease.
- •Disease duration: any
- •Male or female age 30 years or older at time of PD diagnosis.
- •Non-manifesting LRRK2 mutation carriers:
- •Patients must have confirmed LRRK2 mutation
- •Male or female age 30 years or older at Screening.
- •Control (C) Subjects:
- •Male or female age 30 years or older at Screening.
排除标准
- •LRRK2 Parkinson Disease (PD) Subjects:
- •Inability to provide informed consent
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Treatment for cancer in the last 5 years.
- •Idiopathic PD Subjects:
- •Inability to provide informed consent
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Treatment for cancer in the last 5 years.
- •Non-manifesting LRRK2 mutation carriers:
- •Inability to provide informed consent
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Treatment for cancer in the last 5 years.
- •Control Subjects:
- •Inability to provide informed consent
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Treatment for cancer in the last 5 years
结局指标
主要结局
Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs
时间窗: 7 months
Assess the levels of phosphorylated LRRK2 and LRRK2-phosphorylated Rabs, as measures of LRRK2 kinase activity, in PBMCs and neutrophils from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
mtDNA damage in buffy coat
时间窗: 7 months
Assess the levels of mtDNA damage in buffy coat from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
Correlate LRRK2 kinase activity to mtDNA damage
时间窗: 7 months
Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
次要结局
- Assess the ability of the network to efficiently conduct a study(7 months)
- Assess the ability of the network to collect high quality biospecimens(7 months)
- To gauge the willingness of participants to participate in subsequent Fox BioNet studies(7 Months)
研究者
Connie Marras
Neurologist at Toronto Western Hospital Movement Disorders Centre
University Health Network, Toronto
研究点 (5)
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