Fox BioNet Project: LRRK2-002
FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens
1 other identifier
observational
114
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedSeptember 8, 2021
August 1, 2021
2 years
May 22, 2018
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs
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.
7 months
mtDNA damage in buffy coat
Assess the levels of mtDNA damage in buffy coat from LRRK2 PD, idiopathic PD, non-manifesting LRRK2 mutation carriers and healthy controls.
7 months
Correlate LRRK2 kinase activity to mtDNA damage
Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
7 months
Secondary Outcomes (3)
Assess the ability of the network to efficiently conduct a study
7 months
Assess the ability of the network to collect high quality biospecimens
7 months
To gauge the willingness of participants to participate in subsequent Fox BioNet studies
7 Months
Study Arms (4)
Idiopathic Parkinson's Disease patients
Up to 30 Parkinson's Disease patients will be enrolled.
Healthy Controls
Up to 30 Healthy Controls will be enrolled.
LRRK2 G2019S - Manifesting
Up to 30 LRRK2 G2019S Manifesting carriers will be enrolled.
LRRK2 G2019S - Non-Manifesting
Up to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled.
Interventions
Blood and Urine
Eligibility Criteria
30 LRRK2 G2019S Manifesting carriers, 30 Idiopathic PD subjects, 30 LRRK2 G2019S Non-Manifesting Carriers, 30 Healthy Controls
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael J. Fox Foundation for Parkinson's Researchlead
- University Health Network, Torontocollaborator
- Indiana Universitycollaborator
- University of Rochestercollaborator
Study Sites (5)
Charles E. Schmidt College of Medicine, Florida Atlantic University
Boca Raton, Florida, 33431, United States
Northwestern University
Chicago, Illinois, 60208, United States
Columbia University Medical Center
New York, New York, 10032, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Biospecimen
Blood, Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Connie Marras, MD
University Health Network, Toronto
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurologist at Toronto Western Hospital Movement Disorders Centre
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
May 16, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
September 8, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share