Fox BioNet Project: ECV-003

Michael J. Fox Foundation for Parkinson's Research

Status: Completed

Conditions: Parkinson Disease

Treatments: Procedure: Lumbar Puncture

Study type: Observational

Funder types: Other

Identifiers

NCT03775447

ECV-003

Details and patient eligibility

About

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

Full 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

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

38 participants in 2 patient groups

Parkinson's Disease Patients

Description:

* 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.

Treatment:

Procedure: Lumbar Puncture

Healthy Control (HC) Subjects

Description:

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

Treatment:

Procedure: Lumbar Puncture