Parkinson DiseaseNCT03545425
Fox BioNet Project: LRRK2-002
An observational study of Parkinson Disease, run by Michael J. Fox Foundation for Parkinson's Research at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Biofluid samplings
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 May 2018to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 LRRK2 G2019S Manifesting carriers, 30 Idiopathic PD subjects, 30 LRRK2 G2019S Non-Manifesting Carriers, 30 Healthy Controls
Who may be able to join
- 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:
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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:
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Charles E. Schmidt College of Medicine, Florida Atlantic University
Boca Raton, Florida, 33431
Northwestern University
Chicago, Illinois, 60208
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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:
- 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
- Conditions
- Parkinson Disease
- Being tested
- Biofluid samplings
- Keywords
- Parkinson's Disease, Biomarker, LRRK2
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofluid samplingsProcedure or surgery
Blood and Urine
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Parkinson's Disease patients | Up to 30 Parkinson's Disease patients will be enrolled. Receives: Procedure: Biofluid samplings | |
| Healthy Controls | Up to 30 Healthy Controls will be enrolled. Receives: Procedure: Biofluid samplings | |
| LRRK2 G2019S - Manifesting | Up to 30 LRRK2 G2019S Manifesting carriers will be enrolled. Receives: Procedure: Biofluid samplings | |
| LRRK2 G2019S - Non-Manifesting | Up to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled. Receives: Procedure: Biofluid samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 months
Secondary outcomes (3)
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.
Measured: 7 months
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
Measured: 7 months
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
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start16 May 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Marras, University Health Network, Toronto
- Investigators
- Connie Marras, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545425
- Sponsor's protocol ID
- LRRK2002
- Status last verified
- Aug 2021
- First submitted
- 22 May 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoxBioNet: LRRK2-002: Detection of LRRK2 Activity in Human Biospecimens
- ClinicalTrials.gov ID
- NCT03545425
- Acronym / sponsor ID
- LRRK2002
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Biomarker, LRRK2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Indiana University, University of Rochester
- Study start
- 16 May 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's Disease patients | – | Procedure: Biofluid samplingsUp to 30 Parkinson's Disease patients will be enrolled. |
| Healthy Controls | – | Procedure: Biofluid samplingsUp to 30 Healthy Controls will be enrolled. |
| LRRK2 G2019S - Manifesting | – | Procedure: Biofluid samplingsUp to 30 LRRK2 G2019S Manifesting carriers will be enrolled. |
| LRRK2 G2019S - Non-Manifesting | – | Procedure: Biofluid samplingsUp to 30 LRRK2 G2019s Non-Manifesting carriers will be enrolled. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 LRRK2 G2019S Manifesting carriers, 30 Idiopathic PD subjects, 30 LRRK2 G2019S Non-Manifesting Carriers, 30 Healthy Controls
Key inclusion criteria (14 listed)
- 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.
- Patients must meet the MDS criteria for Parkinson's disease.
Key exclusion criteria (16 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofluid samplingsBlood and Urine | Procedure or surgery | Healthy Controls, Idiopathic Parkinson's Disease patients, LRRK2 G2019S - Manifesting, LRRK2 G2019S - Non-Manifesting |
Primary outcome
Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs
Time frame: 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
Time frame: 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
Time frame: 7 months
Correlate LRRK2 kinase activity to mtDNA damage in blood from LRRK2 PD, idiopathic-PD, non-manifesting LRRK2 mutation carriers and healthy controls.
3 secondary outcomes
Assess the ability of the network to efficiently conduct a study
Time frame: 7 months
Assess the ability of the network to collect high quality biospecimens
Time frame: 7 months
To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Time frame: 7 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Marras, MD principal investigator
University Health Network, Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Michael J. Fox Foundation for Parkinson's Research at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphorylated LRRK2 and LRRK2-phosphorylated Rabs (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.