Fox BioNet Project: LRRK2-002

Michael J. Fox Foundation for Parkinson's Research

Status

Completed

Conditions

Parkinson Disease

Treatments

Procedure: Biofluid samplings

Study type

Observational

Funder types

Other

Identifiers

NCT03545425

LRRK2002

Details and patient eligibility

About

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.

Full 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

Enrollment

114 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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