Fox BioNet Project: LRRK2-002
- Conditions
- Parkinson Disease
- Interventions
- Procedure: Biofluid samplings
- Registration Number
- NCT03545425
- Lead Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Controls Biofluid samplings Up to 30 Healthy Controls will be enrolled. LRRK2 G2019S - Non-Manifesting Biofluid samplings Up to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled. Idiopathic Parkinson's Disease patients Biofluid samplings Up to 30 Parkinson's Disease patients will be enrolled. LRRK2 G2019S - Manifesting Biofluid samplings Up to 30 LRRK2 G2019S Manifesting carriers will be enrolled.
- Primary Outcome Measures
Name Time Method Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs 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 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 7 months Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
- Secondary Outcome Measures
Name Time Method Assess the ability of the network to efficiently conduct a study 7 months 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.
Assess the ability of the network to collect high quality biospecimens 7 months 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 7 Months To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Trial Locations
- Locations (5)
Charles E. Schmidt College of Medicine, Florida Atlantic University
🇺🇸Boca Raton, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States