Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2019-04-23
2019-12-18
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Healthy Control (HC) Subjects
• Male or female age 18 years or older at Screening.
Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Interventions
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Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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University Health Network, Toronto
OTHER
Indiana University
OTHER
University of Rochester
OTHER
Michael J. Fox Foundation for Parkinson's Research
OTHER
Responsible Party
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Connie Marras
Neurologist at Toronto Western Hospital Movement Disorders Centre
Locations
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Northwestern University
Chicago, Illinois, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ECV-003
Identifier Type: -
Identifier Source: org_study_id
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