NCT03545425

Fox BioNet Project: LRRK2-002

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Michael J. Fox Foundation for Parkinson's Research · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Biofluid samplings	Blood and Urine

Timeline

• Start date: 2018-05-16
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-06-04
• Last updated: 2021-09-08

Locations

5 sites across 1 country: United States