Fox BioNet Project: ECV-003

Study Overview
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Brief Summary
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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
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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

Official Title
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FoxBioNet: ECV (Extracellular Vesicle) 003

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Lumbar Puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's Disease Patients: A diagnosis of Parkinson's disease in the opinion of the enrolling investigator Disease duration: any Male or female age 18 years or older at time of PD diagnosis. Healthy Controls: •Male or female age 18 years or older at Screening. Exclusion Criteria: Parkinson's Disease Patients: Inability to provide informed consent Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 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. Healthy Controls: Inability to provide informed consent Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 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. Currently pregnant (female participants)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's Disease Patients<br>A diagnosis of Parkinson's disease in the opinion of the enrolling investigator Disease duration: any Male or female age 18 years or older at time of PD diagnosis. | Procedure: Lumbar Puncture<br>* Lumbar Puncture for collection of Cerebrospinal Fluids<br>* Other names: Biofluid Samplings: Blood;|
| Healthy Control (HC) Subjects<br>• Male or female age 18 years or older at Screening. | Procedure: Lumbar Puncture<br>* Lumbar Puncture for collection of Cerebrospinal Fluids<br>* Other names: Biofluid Samplings: Blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power analysis to guide future research | Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes | 1 year | 
| Time from IRB submission to approval by central IRB | Time from IRB submission to approval by central IRB | 3 months | 
| Time from central IRB approval to site approval | Time from central IRB approval to site approval (for those sites requiring administrative review) | 3 months | 
| Time from site selection to contract full execution | Time from site selection to contract full execution | 4 months | 
| Completion of Recruitment | Time from site activation to completion of recruitment. | 6 months | 
| Proportion of samples conforming to collection | Proportion of samples conforming to collection, processing and shipping protocols. | 6 months | 
| Retention | Proportion of participants agreeing to be contacted for future Fox BioNet protocols | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Biomarker, LRRK2, CSF