Fox BioNet Project: ECV-003

Parkinson Disease Clinical Trial

Official title:

FoxBioNet: ECV (Extracellular Vesicle) 003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775447
• Other study ID #: ECV-003
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: August 2021
• Source: Michael J. Fox Foundation for Parkinson's Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Michael J. Fox Foundation for Parkinson's Research	Indiana University, University Health Network, Toronto, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time from IRB submission to approval by central IRB	Time from IRB submission to approval by central IRB	3 months
Secondary	Time from central IRB approval to site approval	Time from central IRB approval to site approval (for those sites requiring administrative review)	3 months
Secondary	Time from site selection to contract full execution	Time from site selection to contract full execution	4 months
Secondary	Completion of Recruitment	Time from site activation to completion of recruitment.	6 months
Secondary	Proportion of samples conforming to collection	Proportion of samples conforming to collection, processing and shipping protocols.	6 months
Secondary	Retention	Proportion of participants agreeing to be contacted for future Fox BioNet protocols	1 year