Fox BioNet Project: LRRK2-002

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-16

Study Completion Date

2020-04-30

Brief Summary

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The overall objective of this study is to determine whether LRRK2 kinase activity and/or mitochondrial DNA (mtDNA) damage could serve as potential biomarkers in PD.

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Detailed Description

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Primary Objectives:

* Assess the levels of phosphorylated LRRK2 and LRRK2-phosphorylated Rabs, as measures of LRRK2 kinase activity, in PBMCs and neutrophils from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
* Assess the levels of mtDNA damage in buffy coat from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
* Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.

Secondary Objectives:

* To assess the ability of the network 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, standardized protocols
* To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Idiopathic Parkinson's Disease patients

Up to 30 Parkinson's Disease patients will be enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Blood and Urine

Healthy Controls

Up to 30 Healthy Controls will be enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Blood and Urine

LRRK2 G2019S - Manifesting

Up to 30 LRRK2 G2019S Manifesting carriers will be enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Blood and Urine

LRRK2 G2019S - Non-Manifesting

Up to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Blood and Urine

Interventions

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Biofluid samplings

Blood and Urine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

LRRK2 Parkinson Disease (PD) Subjects:

* Patients must have confirmed LRRK2 mutation
* Patients must meet the MDS criteria for Parkinson's disease
* Disease duration: any
* Male or female age 30 years or older at time of PD diagnosis.

Idiopathic PD Subjects:

* Patients must meet the MDS criteria for Parkinson's disease.
* Disease duration: any
* Male or female age 30 years or older at time of PD diagnosis.

Non-manifesting LRRK2 mutation carriers:

* Patients must have confirmed LRRK2 mutation
* Male or female age 30 years or older at Screening.

Control (C) Subjects:

* Male or female age 30 years or older at Screening.

Exclusion Criteria

LRRK2 Parkinson Disease (PD) Subjects:

* Inability to provide informed consent
* 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.
* Treatment for cancer in the last 5 years.

Idiopathic PD Subjects:

* Inability to provide informed consent
* 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.
* Treatment for cancer in the last 5 years.

Non-manifesting LRRK2 mutation carriers:

* Inability to provide informed consent
* 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.
* Treatment for cancer in the last 5 years.

Control Subjects:

* Inability to provide informed consent
* 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.
* Treatment for cancer in the last 5 years

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes