Status:
COMPLETED
Fox BioNet Project: ECV-003
Lead Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsors:
University Health Network, Toronto
Indiana University
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03775447
Start Date
April 23 2019
End Date
December 18 2019
Last Update
September 8 2021
Active Locations (3)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107