FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - Any |
Updated: | 8/22/2018 |
Start Date: | August 8, 2017 |
End Date: | March 12, 2018 |
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.
phosphorylated a-synuclein assay in cerebrospinal fluid and blood.
Specific aims to accomplish this objective are:
1. Assess the reliability of oligomeric and phosphorylated a-synuclein concentration
between two different oligomeric and three phosphorylated asynuclein assays.
2. Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations
between laboratories
3. Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations
between cerebrospinal fluid and blood.
1.2. Secondary Objectives
1. 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.
2. To assess the ability of the network to collect high quality biospecimens adhering to
agreed-upon protocols.
3. To gauge the willingness of participants to participate in subsequent Fox BioNet studies
1. Assess the reliability of oligomeric and phosphorylated a-synuclein concentration
between two different oligomeric and three phosphorylated asynuclein assays.
2. Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations
between laboratories
3. Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations
between cerebrospinal fluid and blood.
1.2. Secondary Objectives
1. 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.
2. To assess the ability of the network to collect high quality biospecimens adhering to
agreed-upon protocols.
3. To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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)
We found this trial at
5
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Rizwan Akhtar, MD, PhD
Phone: 215-829-6952
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-9885
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Jankovic, MD
Phone: 713-798-3951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Jennifer Goldman, MD
Phone: 312-942-7391
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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