FoxBioNet: ECV (Extracellular Vesicle) 004

NCT04603326 | Completed

• 1 other identifier: ECV-004
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this study is to identify reliable markers of LRRK2 activity in human CSF.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Biomarker; LRRK2; CSF

Outcome Measures

Primary Outcomes (1)

• Assay Evaluation

  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).

  1 year

Study Arms (4)

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

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

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

Control (C) Participants:

Age 30 years or older at date of informed consent.

Procedure: Lumbar Puncture

Interventions

Lumbar Puncture PROCEDURE

Lumbar Puncture for collection of Cerebrospinal Fluids

Also known as: Whole Blood Collection

Control (C) Participants:; Idiopathic PD (iPD) Particpants:; LRRK2 Parkinson Disease (PD) Participants:; Non-manifesting LRRK2 mutation carriers

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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:
• Ability to provide informed consent
• Confirmed LRRK2 G2019S mutation
• Meet the MDS criteria for Parkinson's disease

Sponsors & Collaborators

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

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Trustees of Columbia University

New York, New York, 10032, United States

Location

Oregon Health Sciences Univeristy

Portland, Oregon, 97239, United States

Location

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebro-Spinal Fluids Immune Cell Collection from Whole Blood

MeSH Terms

Conditions

Parkinson Disease

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at University Health Network, University of Toronto

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 26, 2020
• Study Start: May 6, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (4)