Fox BioNet Project: LRRK2-002
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - Any |
Updated: | 6/16/2018 |
Start Date: | May 16, 2018 |
End Date: | December 2018 |
Contact: | Julie Racioppa |
Email: | jraciopp@uhnresearch.ca |
Phone: | 416-603-5800 |
FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens
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.
mitochondrial DNA (mtDNA) damage could serve as potential biomarkers in PD.
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
- 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
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
We found this trial at
5
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Rizwan Akhtar, MD, PhD
Phone: 215-829-6952
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Boca Raton, Florida 33431
Principal Investigator: James E. Galvin, MD, MPH
Phone: 561-297-4802
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Tanya Simuni, MD
Phone: 312-503-5645
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Roy Alcalay
Phone: 212-305-4233
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Portland, Oregon 97227
Principal Investigator: Penelope Hogarth, MD
Phone: 503-494-6838
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