Parkinson DiseaseNCT04603326
FoxBioNet: ECV (Extracellular Vesicle) 004
An observational study of Parkinson Disease, run by Michael J. Fox Foundation for Parkinson's Research at 4 sites in United States.
Trial summary
The goal of this study is to identify reliable markers of LRRK2 activity in human CSF. 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?
- Lumbar Puncture
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 May 2021to 1 Jul 2023
- 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: Approximately 140 participants will be enrolled to participate in this study, with a goal of enrolling 30 non-manifesting LRRK2 carriers, 30 LRRK2 Parkinson's Disease (PD), 40 idiopathic PD, and 40 healthy controls.
Who may be able to join
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
- Age 30 years or older at date of informed consent.
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
- Meet the MDS criteria for Parkinson's disease
Show all 14Show fewer
- Disease duration: any
- Age 30 years or older at time of PD diagnosis.
- Ability to provide informed consent
- Meet the MDS criteria for Parkinson's disease.
- Disease duration: any
- Age 30 years or older at time of PD diagnosis.
- Ability to provide informed consent
- Age 30 years or older at date of informed consent.
Who cannot join
- Inability to provide informed consent
- Known GBA mutation carrier
- 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
- The presence of rest tremor, bradykinesia or rigidity.
- The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
Show all 40Show fewer
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
- LRRK2 Parkinson Disease (PD) Participants:
- Known GBA mutation carrier
- 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
- Idiopathic PD (iPD) Particpants:
- Known LRRK2 G2019S and/or GBA mutation carrier
- 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
- Control (C) Participants:
- Known GBA mutation carrier
- In the absence of prior genetic testing for LRRK2 G2019S mutations: Family history of Parkinson's disease is an exclusion criterion. If genetic testing for LRRK2 G2019S mutations has been performed and is negative, individuals with a family history of PD may be enrolled.
- The presence of rest tremor, bradykinesia or rigidity.
- The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or targeted therapy. Individuals with cancers that have not been treated with systemic chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to enroll in the study.
- Diagnosis of an autoimmune disorder.
- Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture and that cannot be safely paused in the opinion of the site investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University
Chicago, Illinois, 60611
The Trustees of Columbia University
New York, New York, 10032
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health Sciences Univeristy
Portland, Oregon, 97239
About this study
The goal of this study is to identify reliable markers of LRRK2 activity in human CSF.
Read the detailed description
Specific aims of this project are:
Primary Objectives:
To evaluate each assay performance for its ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS). Assay performance will be assessed and those demonstrating high sensitivity and consistency will be considered for further development.
Secondary Objectives:
To assess the ability of the assay or a combination of assays to differentiate pathogenic LRRK2 variant manifesting and non-manifesting carriers, idiopathic PD and healthy non-carriers.
- Conditions
- Parkinson Disease
- Being tested
- Lumbar Puncture
- Keywords
- Parkinson's Disease, Biomarker, LRRK2, CSF
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar PunctureProcedure or surgery
Also called Whole Blood Collection
Lumbar Puncture for collection of Cerebrospinal Fluids
| Study group | Role | What they receive |
|---|---|---|
| Non-manifesting LRRK2 mutation carriers | Patients must have confirmed LRRK2 G2019S mutation Age 30 years or older at date of informed consent. Receives: Procedure: Lumbar Puncture | |
| LRRK2 Parkinson Disease (PD) Participants: | Patients must have confirmed LRRK2 G2019S mutation Patients must meet the MDS criteria for Parkinson's disease Disease duration: any Age 30 years or older at time of PD diagnosis. Receives: Procedure: Lumbar Puncture | |
| Idiopathic PD (iPD) Particpants: | Patients must meet the MDS criteria for Parkinson's disease. Disease duration: any Age 30 years or older at time of PD diagnosis. Receives: Procedure: Lumbar Puncture | |
| Control (C) Participants: | Age 30 years or older at date of informed consent. Receives: Procedure: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay Evaluation
Evaluate each assay performance for ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start6 May 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603326
- Sponsor's protocol ID
- ECV-004
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2020
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoxBioNet: ECV (Extracellular Vesicle) 004
- ClinicalTrials.gov ID
- NCT04603326
- Acronym / sponsor ID
- ECV-004
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Biomarker, LRRK2, CSF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- Indiana University, University of Rochester, University Health Network, Toronto
- Study start
- 6 May 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Oct 2020 (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 goal of this study is to identify reliable markers of LRRK2 activity in human CSF.
Detailed description
Specific aims of this project are:
Primary Objectives:
To evaluate each assay performance for its ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS). Assay performance will be assessed and those demonstrating high sensitivity and consistency will be considered for further development.
Secondary Objectives:
To assess the ability of the assay or a combination of assays to differentiate pathogenic LRRK2 variant manifesting and non-manifesting carriers, idiopathic PD and healthy non-carriers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-manifesting LRRK2 mutation carriers | – | Procedure: Lumbar PuncturePatients must have confirmed LRRK2 G2019S mutation Age 30 years or older at date of informed consent. |
| LRRK2 Parkinson Disease (PD) Participants: | – | Procedure: Lumbar PuncturePatients must have confirmed LRRK2 G2019S mutation Patients must meet the MDS criteria for Parkinson's disease Disease duration: any Age 30 years or older at time of PD diagnosis. |
| Idiopathic PD (iPD) Particpants: | – | Procedure: Lumbar PuncturePatients must meet the MDS criteria for Parkinson's disease. Disease duration: any Age 30 years or older at time of PD diagnosis. |
| Control (C) Participants: | – | Procedure: Lumbar PunctureAge 30 years or older at date of informed consent. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 140 participants will be enrolled to participate in this study, with a goal of enrolling 30 non-manifesting LRRK2 carriers, 30 LRRK2 Parkinson's Disease (PD), 40 idiopathic PD, and 40 healthy controls.
Key inclusion criteria (14 listed)
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
- Age 30 years or older at date of informed consent.
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
Key exclusion criteria (40 listed)
- Inability to provide informed consent
- Known GBA mutation carrier
- 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. Participants that have had a 6 - month washout period between ending participation in a clinical trial with an investigational agent and enrollment into the ECV-004 study are eligible.
- The presence of rest tremor, bradykinesia or rigidity.
- The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
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 |
|---|---|---|
| Lumbar PunctureAlso: Whole Blood CollectionLumbar Puncture for collection of Cerebrospinal Fluids | Procedure or surgery | Control (C) Participants:, Idiopathic PD (iPD) Particpants:, LRRK2 Parkinson Disease (PD) Participants:, Non-manifesting LRRK2 mutation carriers |
Primary outcome
Assay Evaluation
Time frame: 1 year
Evaluate each assay performance for ability to detect LRRK2, its activity and/or the detection and activity of the pathways it impacts using a variety of different approaches (quantitative western blot, immunoassays and LC-MS).
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 16 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 4 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 40 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Assay Evaluation (time frame: 1 year). 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 16 Oct 2023.