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FoxBioNet: ECV (Extracellular Vesicle) 004

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603326
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : January 31, 2022
Sponsor:
Collaborators:
Indiana University
University of Rochester
University Health Network, Toronto
Information provided by (Responsible Party):
Connie Marras, University Health Network, Toronto

Study Description
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Brief Summary:
The goal of this study is to identify reliable markers of LRRK2 activity in human CSF.

Condition or disease Intervention/treatment
Parkinson Disease Procedure: Lumbar Puncture

Detailed Description:

Specific aims of this project are:

Primary Objectives:

To evaluate each assay performance for its ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS). Assay performance will be assessed and those demonstrating high sensitivity and consistency will be considered for further development.

Secondary Objectives:

To assess the ability of the assay or a combination of assays to differentiate pathogenic LRRK2 variant manifesting and non-manifesting carriers, idiopathic PD and healthy non-carriers.

Study Design
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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: FoxBioNet: ECV (Extracellular Vesicle) 004
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-manifesting LRRK2 mutation carriers
Patients must have confirmed LRRK2 G2019S mutation Age 30 years or older at date of informed consent.
 Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Whole Blood Collection
LRRK2 Parkinson Disease (PD) Participants:
Patients must have confirmed LRRK2 G2019S mutation Patients must meet the MDS criteria for Parkinson's disease Disease duration: any Age 30 years or older at time of PD diagnosis.
 Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Whole Blood Collection
Idiopathic PD (iPD) Particpants:
Patients must meet the MDS criteria for Parkinson's disease. Disease duration: any Age 30 years or older at time of PD diagnosis.
 Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Whole Blood Collection
Control (C) Participants:
Age 30 years or older at date of informed consent.
 Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Whole Blood Collection


Outcome Measures
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Primary Outcome Measures :
  1. Assay Evaluation [ Time Frame: 1 year ]
    Evaluate each assay performance for ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS).


Biospecimen Retention:   Samples With DNA
Cerebro-Spinal Fluids Immune Cell Collection from Whole Blood

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 140 participants will be enrolled to participate in this study, with a goal of enrolling 30 non-manifesting LRRK2 carriers, 30 LRRK2 Parkinson's Disease (PD), 40 idiopathic PD, and 40 healthy controls.
Criteria

Non-manifesting LRRK2 mutation carriers

Inclusion:

  • Ability to provide informed consent
  • Confirmed LRRK2 G2019S mutation
  • Age 30 years or older at date of informed consent.

Exclusion:

  • Inability to provide informed consent
  • Known GBA mutation carrier
  • 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
  • The presence of rest tremor, bradykinesia or rigidity.
  • The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
  • Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
  • Diagnosis of an autoimmune disorder
  • Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
  • Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Diagnosis of dementia
  • Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample

LRRK2 Parkinson Disease (PD) Participants:

Inclusion:

  • Ability to provide informed consent
  • Confirmed LRRK2 G2019S mutation
  • Meet the MDS criteria for Parkinson's disease
  • Disease duration: any
  • Age 30 years or older at time of PD diagnosis.

Exclusion:

  • Known GBA mutation carrier
  • 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
  • Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
  • Diagnosis of an autoimmune disorder
  • Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
  • Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Diagnosis of dementia
  • Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample

Idiopathic PD (iPD) Particpants:

Inclusion:

  • Ability to provide informed consent
  • Meet the MDS criteria for Parkinson's disease.
  • Disease duration: any
  • Age 30 years or older at time of PD diagnosis.

Exclusion:

  • Known LRRK2 G2019S and/or GBA mutation carrier
  • 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
  • Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
  • Diagnosis of an autoimmune disorder
  • Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
  • Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Diagnosis of dementia
  • Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample

Control (C) Participants:

Inclusion:

  • Ability to provide informed consent
  • Age 30 years or older at date of informed consent.

Exclusion:

  • Known GBA mutation carrier
  • In the absence of prior genetic testing for LRRK2 G2019S mutations: Family history of Parkinson's disease is an exclusion criterion. If genetic testing for LRRK2 G2019S mutations has been performed and is negative, individuals with a family history of PD may be enrolled.
  • The presence of rest tremor, bradykinesia or rigidity.
  • The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
  • Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
  • Diagnosis of an autoimmune disorder.
  • Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
  • Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Diagnosis of dementia
  • Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603326


Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Karen Williams    312-503-5645    k-williams8@northwestern.edu   
Principal Investigator: Tanya Simuni, MD         
United States, New York
The Trustees of Columbia University Recruiting
New York, New York, United States, 10032
Contact: Alexander Haimovich    212-305-4233    Ah3912@cumc.columbia.edu   
Principal Investigator: Roy Alcalay, MD         
United States, Oregon
Oregon Health Sciences Univeristy Recruiting
Portland, Oregon, United States, 97239
Contact: Alison Freed    503-494-6838    freeal@ohsu.edu   
Principal Investigator: Penelope Hogarth, MD         
United States, Pennsylvania
The Trustees of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Whitney Hartstone, DO, MPH    215-829-6500    Whitney.Hartstone@Pennmedicine.upenn.edu   
Principal Investigator: Thomas Tropea, DO, MPH, MSTR         
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
Indiana University
University of Rochester
University Health Network, Toronto
More Information
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Responsible Party: Connie Marras, Associate Professor at University Health Network, University of Toronto, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04603326    
Other Study ID Numbers: ECV-004
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Connie Marras, University Health Network, Toronto:
Parkinson's Disease
Biomarker
LRRK2
CSF
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases