NCT03775447

Fox BioNet Project: ECV-003

FoxBioNet: ECV (Extracellular Vesicle) 003

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Michael J. Fox Foundation for Parkinson's Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to optimize pre-analytical cerebrospinal fluid (CSF) extracellular vesicle isolation protocols for increasing the detection of LRRK2 activity in human CSF

Detailed description

Specific aims to accomplish this objective are: PRIMARY OBJECTIVES: * To evaluate a series of extracellular vesicle isolation methods for their ability to enrich for LRRK2 and increase the detection of LRRK2 in CSF samples. * To compare the measurements of LRRK2, p1292 LRRK2, Rabs and pRabs from the ECVs isolated using each method. * To assess the inter-lab reliability of each method SECONDARY OBJECTIVES * To assess the ability of the network of sites 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 protocols. * To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Lumbar Puncture	Lumbar Puncture for collection of Cerebrospinal Fluids

Timeline

• Start date: 2019-04-23
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2018-12-14
• Last updated: 2021-09-08

Locations

3 sites across 1 country: United States