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
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
Study Type
OBSERVATIONAL
Enrollment
38
Lumbar Puncture for collection of Cerebrospinal Fluids
Northwestern University
Chicago, Illinois, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
For methods involving immunoprecipitation: Increase in peptide spectral matches on mass spectrometry For methods amenable to antibody-based detection: increase in LRRK2 intensity on Western blotting (arbitrary units).
Time frame: 1 year
Power analysis to guide future research
Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes
Time frame: 1 year
Time from IRB submission to approval by central IRB
Time from IRB submission to approval by central IRB
Time frame: 3 months
Time from central IRB approval to site approval
Time from central IRB approval to site approval (for those sites requiring administrative review)
Time frame: 3 months
Time from site selection to contract full execution
Time from site selection to contract full execution
Time frame: 4 months
Completion of Recruitment
Time from site activation to completion of recruitment.
Time frame: 6 months
Proportion of samples conforming to collection
Proportion of samples conforming to collection, processing and shipping protocols.
Time frame: 6 months
Retention
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Proportion of participants agreeing to be contacted for future Fox BioNet protocols
Time frame: 1 year