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Completed

NCT Number: NCT03775447

Fox BioNet Project: ECV-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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lumbar Puncture

Procedure

Lumbar Puncture for collection of Cerebrospinal Fluids

Other names: Biofluid Samplings: Blood

Primary outcomes

  1. degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used

    Time frame: 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 outcomes

  1. Power analysis to guide future research

    Time frame: 1 year

    Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes

  2. Time from IRB submission to approval by central IRB

    Time frame: 3 months

    Time from IRB submission to approval by central IRB

  3. Time from central IRB approval to site approval

    Time frame: 3 months

    Time from central IRB approval to site approval (for those sites requiring administrative review)

  4. Time from site selection to contract full execution

    Time frame: 4 months

    Time from site selection to contract full execution

  5. Completion of Recruitment

    Time frame: 6 months

    Time from site activation to completion of recruitment.

  6. Proportion of samples conforming to collection

    Time frame: 6 months

    Proportion of samples conforming to collection, processing and shipping protocols.

  7. Retention

    Time frame: 1 year

    Proportion of participants agreeing to be contacted for future Fox BioNet protocols

Sponsors and collaborators

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Other

Collaborators

  • Indiana University
  • University Health Network, Toronto
  • University of Rochester

Registry information

Official study title

FoxBioNet: ECV (Extracellular Vesicle) 003

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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