FoxBioNet: ECV (Extracellular Vesicle) 004
- Conditions
- Parkinson Disease
- Interventions
- Procedure: Lumbar Puncture
- Registration Number
- NCT04603326
- Lead Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Brief Summary
The goal of this study is to identify reliable markers of LRRK2 activity in human CSF.
- Detailed Description
Specific aims of this project are:
Primary Objectives:
To evaluate each assay performance for its ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS). Assay performance will be assessed and those demonstrating high sensitivity and consistency will be considered for further development.
Secondary Objectives:
To assess the ability of the assay or a combination of assays to differentiate pathogenic LRRK2 variant manifesting and non-manifesting carriers, idiopathic PD and healthy non-carriers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-manifesting LRRK2 mutation carriers Lumbar Puncture Patients must have confirmed LRRK2 G2019S mutation Age 30 years or older at date of informed consent. LRRK2 Parkinson Disease (PD) Participants: Lumbar Puncture Patients must have confirmed LRRK2 G2019S mutation Patients must meet the MDS criteria for Parkinson's disease Disease duration: any Age 30 years or older at time of PD diagnosis. Idiopathic PD (iPD) Particpants: Lumbar Puncture Patients must meet the MDS criteria for Parkinson's disease. Disease duration: any Age 30 years or older at time of PD diagnosis. Control (C) Participants: Lumbar Puncture Age 30 years or older at date of informed consent.
- Primary Outcome Measures
Name Time Method Assay Evaluation 1 year Evaluate each assay performance for ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Northwestern University
🇺🇸Chicago, Illinois, United States
Oregon Health Sciences Univeristy
🇺🇸Portland, Oregon, United States
The Trustees of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Trustees of Columbia University
🇺🇸New York, New York, United States