Fox BioNet Project: LRRK2-002
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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:
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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.
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Idiopathic Parkinson's Disease patients Up to 30 Parkinson's Disease patients will be enrolled. |
Procedure: Biofluid samplings
Blood and Urine
|
| Healthy Controls Up to 30 Healthy Controls will be enrolled. |
Procedure: Biofluid samplings
Blood and Urine
|
| LRRK2 G2019S - Manifesting Up to 30 LRRK2 G2019S Manifesting carriers will be enrolled. |
Procedure: Biofluid samplings
Blood and Urine
|
| LRRK2 G2019S - Non-Manifesting Up to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled. |
Procedure: Biofluid samplings
Blood and Urine
|
Outcome Measures
Primary Outcome Measures
- Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs [7 months]
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.
- mtDNA damage in buffy coat [7 months]
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 [7 months]
Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
Secondary Outcome Measures
- Assess the ability of the network to efficiently conduct a study [7 months]
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.
- Assess the ability of the network to collect high quality biospecimens [7 months]
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 [7 Months]
To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Eligibility Criteria
Criteria
Inclusion Criteria:
LRRK2 Parkinson Disease (PD) Subjects:
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Patients must have confirmed LRRK2 mutation
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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:
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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:
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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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charles E. Schmidt College of Medicine, Florida Atlantic University | Boca Raton | Florida | United States | 33431 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60208 |
| 3 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 4 | Oregon Health and Sciences University | Portland | Oregon | United States | 97239 |
| 5 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- University Health Network, Toronto
- Indiana University
- University of Rochester
Investigators
- Principal Investigator: Connie Marras, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LRRK2002