Fox BioNet Project: ECV-003
- Conditions
- Parkinson Disease
- Interventions
- Procedure: Lumbar Puncture
- Registration Number
- NCT03775447
- Lead Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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.
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's Disease Patients Lumbar Puncture * 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 Control (HC) Subjects Lumbar Puncture • Male or female age 18 years or older at Screening.
- Primary Outcome Measures
Name Time Method degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used 1 year 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).
- Secondary Outcome Measures
Name Time Method Completion of Recruitment 6 months Time from site activation to completion of recruitment.
Time from IRB submission to approval by central IRB 3 months Time from IRB submission to approval by central IRB
Power analysis to guide future research 1 year Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes
Time from site selection to contract full execution 4 months Time from site selection to contract full execution
Time from central IRB approval to site approval 3 months Time from central IRB approval to site approval (for those sites requiring administrative review)
Proportion of samples conforming to collection 6 months Proportion of samples conforming to collection, processing and shipping protocols.
Retention 1 year Proportion of participants agreeing to be contacted for future Fox BioNet protocols
Trial Locations
- Locations (3)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States