Fox BioNet Project: LRRK2-002

Michael J. Fox Foundation for Parkinson's Research114 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Parkinson Disease

Interventions

Biofluid samplingsPROCEDURE

Blood and Urine

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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

Locations (5)

Charles E. Schmidt College of Medicine, Florida Atlantic University

Boca Raton, Florida, United States

Northwestern University

Chicago, Illinois, United States

Columbia University Medical Center

New York, New York, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs

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.

Time frame: 7 months

mtDNA damage in buffy coat

Assess the levels of mtDNA damage in buffy coat from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.

Time frame: 7 months

Correlate LRRK2 kinase activity to mtDNA damage

Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.

Time frame: 7 months

Secondary Outcomes

Assess the ability of the network to efficiently conduct a study

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.

Time frame: 7 months

Assess the ability of the network to collect high quality biospecimens

To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon, standardized protocols

Time frame: 7 months

To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Time frame: 7 Months

Data from ClinicalTrials.gov

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