Clinical trial NCT03775447: Fox BioNet Project: ECV-003
Official title: FoxBioNet: ECV (Extracellular Vesicle) 003
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Biomarker
LRRK2
CSF
Lead sponsor: Michael J. Fox Foundation for Parkinson's Research
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Indiana University
name: University of Rochester
First posted: 2018-12-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 36 subjects will be enrolled to participate in this study, a combination of Parkinson Disease (PD) (any stage) and Healthy Controls in no specified proportion.

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

Eligibility criteria: 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)

Primary outcomes:
measure: degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
timeFrame: 1 year
Secondary outcomes:
measure: Power analysis to guide future research
timeFrame: 1 year
measure: Time from IRB submission to approval by central IRB
timeFrame: 3 months
measure: Time from central IRB approval to site approval
timeFrame: 3 months
measure: Time from site selection to contract full execution
timeFrame: 4 months
measure: Completion of Recruitment
timeFrame: 6 months
measure: Proportion of samples conforming to collection
timeFrame: 6 months
measure: Retention
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: