Parkinson DiseaseSAVE001NCT03170063
FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)
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 compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood. 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?
- Procedure/Surgery: Biofluid samplings
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Aug 2017to 12 Mar 2018
- 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 Parkinson's Disease Subjects, and 20 Healthy Controls. Potential participants will be identified by the study sites through their patient population or through Fox Trial Finder.
Who may be able to join
- Parkinson's Disease 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.
- Control Subjects
- Male or female age 30 years or older at Screening.
Who cannot join
- Parkinson's Disease Subjects
- Inability to provide informed consent
- Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- 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.
- Control Subjects
Show all 12Show fewer
- Inability to provide informed consent
- Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- 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.
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612-3863
Baylor College of Medicine
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) (SAVE001)
The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.
Read the detailed description
Specific aims to accomplish this objective are:
- Assess the reliability of oligomeric and phosphorylated a-synuclein concentration between two different oligomeric and three phosphorylated asynuclein assays.
- Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations between laboratories
- Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations between cerebrospinal fluid and blood.
1.2. Secondary Objectives
- To assess the ability of the network of pilot sites 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 protocols.
- To gauge the willingness of participants to participate in subsequent Fox BioNet studies
- Conditions
- Parkinson Disease
- Being tested
- Procedure/Surgery: Biofluid samplings
- Keywords
- Parkinson's Disease, Alpha-Synuclein, Biomarker
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Biofluid samplingsProcedure or surgery
Biofluid samplings (blood and cerebrospinal fluid (CSF))
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Subjects | Up to 30 Parkinson's Disease patients will be enrolled. Receives: Procedure: Procedure/Surgery: Biofluid samplings | |
| Healthy Controls | Up to 20 healthy controls will be enrolled. Receives: Procedure: Procedure/Surgery: Biofluid samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oligomeric and PS129 α-syn levels
CSF, serum, and plasma will be analyzed using oligomeric and pS129 assays. The outcome will be expressed as a concentration of modified (pS129 or oligomeric) synuclein or as a ratio of specific species to total synuclein levels.
Measured: 3 Months
Secondary outcomes (6)
Time from IRB submission to approval by central IRB
To assess time taken from submission of proposal to IRB to approval by the IRB
Measured: 3 Months
Time from central IRB approval to site approval (for those sites requiring administrative review)
To assess time taken from approval by IRB to approval by internal boards for sites.
Measured: 3 Months
Time from site selection to contract full execution
To assess the ability of the network of pilot sites 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: 3 Months
Time from site activation to recruitment of 10 participants
Time taken from site activation to recruitment of 10 participants
Measured: 3 Months
Proportion of samples conforming to collection, processing and shipping protocols.
To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.
Measured: 3 Months
Proportion of participants agreeing to be contacted for future Fox BioNet protocols
To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start8 Aug 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Indiana University, ICON Clinical Research
- 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
- NCT03170063
- Sponsor's protocol ID
- SAVE001
- Acronym
- SAVE001
- Status last verified
- Aug 2018
- First submitted
- 26 May 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) (SAVE001)
- ClinicalTrials.gov ID
- NCT03170063
- Acronym / sponsor ID
- SAVE001 / SAVE001
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Alpha-Synuclein, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Indiana University, ICON Clinical Research
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 30 May 2017 (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 compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.
Detailed description
Specific aims to accomplish this objective are:
- Assess the reliability of oligomeric and phosphorylated a-synuclein concentration between two different oligomeric and three phosphorylated asynuclein assays.
- Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations between laboratories
- Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations between cerebrospinal fluid and blood.
1.2. Secondary Objectives
- To assess the ability of the network of pilot sites 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 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Subjects | – | Procedure: Procedure/Surgery: Biofluid samplingsUp to 30 Parkinson's Disease patients will be enrolled. |
| Healthy Controls | – | Procedure: Procedure/Surgery: Biofluid samplingsUp to 20 healthy controls will be enrolled. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 Parkinson's Disease Subjects, and 20 Healthy Controls. Potential participants will be identified by the study sites through their patient population or through Fox Trial Finder.
Key inclusion criteria (6 listed)
- Parkinson's Disease 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.
- Control Subjects
Key exclusion criteria (12 listed)
- Parkinson's Disease Subjects
- Inability to provide informed consent
- Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- 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 |
|---|---|---|
| Procedure/Surgery: Biofluid samplingsBiofluid samplings (blood and cerebrospinal fluid (CSF)) | Procedure or surgery | Healthy Controls, Parkinson's Disease Subjects |
Primary outcome
Oligomeric and PS129 α-syn levels
Time frame: 3 Months
CSF, serum, and plasma will be analyzed using oligomeric and pS129 assays. The outcome will be expressed as a concentration of modified (pS129 or oligomeric) synuclein or as a ratio of specific species to total synuclein levels.
6 secondary outcomes
Time from IRB submission to approval by central IRB
Time frame: 3 Months
Time from central IRB approval to site approval (for those sites requiring administrative review)
Time frame: 3 Months
Time from site selection to contract full execution
Time frame: 3 Months
Time from site activation to recruitment of 10 participants
Time frame: 3 Months
Proportion of samples conforming to collection, processing and shipping protocols.
Time frame: 3 Months
Proportion of participants agreeing to be contacted for future Fox BioNet protocols
Time frame: 3 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 20 Aug 2018.
- 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 6 inclusion and 12 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 20 Aug 2018. 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?
Oligomeric and PS129 α-syn levels (time frame: 3 Months). 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 20 Aug 2018.