Fox BioNet Project: LRRK2-002

FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens

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

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