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

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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.

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

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
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Tanya Simuni, MD
Phone: 312-503-5645
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Boca Raton, Florida 33431
Principal Investigator: James E. Galvin, MD, MPH
Phone: 561-297-4802
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Boca Raton, FL
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630 W 168th St
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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3451 Walnut St
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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Portland, Oregon 97227
Principal Investigator: Penelope Hogarth, MD
Phone: 503-494-6838
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Portland, OR
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