Fox BioNet Project: ECV-003

FoxBioNet: ECV (Extracellular Vesicle) 003

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Lumbar Puncture

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

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Lumbar Puncture; Lumbar Puncture for collection of Cerebrospinal Fluids; Other Names: Biofluid Samplings: Blood
Healthy Control (HC) Subjects; • Male or female age 18 years or older at Screening.	Procedure: Lumbar Puncture; Lumbar Puncture for collection of Cerebrospinal Fluids; Other Names: Biofluid Samplings: Blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power analysis to guide future research	Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes	1 year
Time from IRB submission to approval by central IRB	Time from IRB submission to approval by central IRB	3 months
Time from central IRB approval to site approval	Time from central IRB approval to site approval (for those sites requiring administrative review)	3 months
Time from site selection to contract full execution	Time from site selection to contract full execution	4 months
Completion of Recruitment	Time from site activation to completion of recruitment.	6 months
Proportion of samples conforming to collection	Proportion of samples conforming to collection, processing and shipping protocols.	6 months
Retention	Proportion of participants agreeing to be contacted for future Fox BioNet protocols	1 year

Collaborators and Investigators

• Sponsor: Michael J. Fox Foundation for Parkinson's Research
• Collaborators: University Health Network, Toronto; University of Rochester; Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Biomarker; Parkinson's Disease; CSF; LRRK2
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ECV-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No