Parkinson Disease
Conditions
Keywords
Parkinson's Disease, Biomarker, LRRK2, CSF
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
Interventions
PROCEDURELumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Sponsors
University Health Network, Toronto
Indiana University
University of Rochester
Michael J. Fox Foundation for Parkinson's Research
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time from IRB submission to approval by central IRB | 3 months | Time from IRB submission to approval by central IRB |
| Time from central IRB approval to site approval | 3 months | Time from central IRB approval to site approval (for those sites requiring administrative review) |
| Time from site selection to contract full execution | 4 months | Time from site selection to contract full execution |
| 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 |
| 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 |
| Completion of Recruitment | 6 months | Time from site activation to completion of recruitment. |
Countries
United States
Outcome results
None listed