Fox BioNet Project: ECV-003
Completed
Conditions studied: Parkinson Disease
In brief
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
Key facts
- Study ID
- NCT03775447
- Run by
- Michael J. Fox Foundation for Parkinson's Research
- People needed
- 38
- Starts
- 2019-04-23
- Expected to finish
- 2019-12-18
- Last updated by the study team
- 2021-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Northwestern University — Chicago, Illinois, United States
- Oregon Health and Sciences University — Portland, Oregon, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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