Fox BioNet Project: ECV-003

NCT03775447 | Completed

• 1 other identifier: ECV-003
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Biomarker; LRRK2; CSF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Power analysis to guide future research

  1 year

• Time from IRB submission to approval by central IRB

  3 months

• Time from central IRB approval to site approval

  3 months

• Time from site selection to contract full execution

  4 months

• Completion of Recruitment

  6 months

Study Arms (2)

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

Healthy Control (HC) Subjects

• Male or female age 18 years or older at Screening.

Procedure: Lumbar Puncture

Interventions

Lumbar Puncture PROCEDURE

Lumbar Puncture for collection of Cerebrospinal Fluids

Also known as: Biofluid Samplings: Blood

Healthy Control (HC) Subjects; Parkinson's Disease Patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebro-Spinal Fluids

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: Neurologist at Toronto Western Hospital Movement Disorders Centre

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 14, 2018
• Study Start: April 23, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)