Fox BioNet Project: LRRK2-002

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03545425

Enrollment

114

Registered

2018-06-04

Start date

2018-05-16

Completion date

2020-04-30

Last updated

2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson's Disease, Biomarker, LRRK2

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

Interventions

PROCEDUREBiofluid samplings

Blood and Urine

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026