Fox BioNet Project: LRRK2-002

Parkinson Disease Clinical Trial

Official title:

FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545425
• Other study ID #: LRRK2002
• Status: Completed
• Start date: May 16, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2021
• Source: Michael J. Fox Foundation for Parkinson's Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Biofluid samplings
Blood and Urine

Locations

Country	Name	City	State
United States	Charles E. Schmidt College of Medicine, Florida Atlantic University	Boca Raton	Florida
United States	Northwestern University	Chicago	Illinois
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Michael J. Fox Foundation for Parkinson's Research	Indiana University, University Health Network, Toronto, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Assess the ability of the network to efficiently conduct a study	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.	7 months
Secondary	Assess the ability of the network to collect high quality biospecimens	To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon, standardized protocols	7 months
Secondary	To gauge the willingness of participants to participate in subsequent Fox BioNet studies	To gauge the willingness of participants to participate in subsequent Fox BioNet studies	7 Months