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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Indiana University | OTHER |
| ICON Clinical Research | INDUSTRY |
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The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.
Specific aims to accomplish this objective are:
1.2. Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease Subjects | Up to 30 Parkinson's Disease patients will be enrolled. |
| |
| Healthy Controls | Up to 20 healthy controls will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Surgery: Biofluid samplings | Procedure | Biofluid samplings (blood and cerebrospinal fluid (CSF)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from IRB submission to approval by central IRB | To assess time taken from submission of proposal to IRB to approval by the IRB | 3 Months |
| Time from central IRB approval to site approval (for those sites requiring administrative review) |
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Inclusion Criteria:
Parkinson's Disease Subjects
Control Subjects
Exclusion Criteria:
Parkinson's Disease Subjects
Control Subjects
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Connie Marras, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612-3863 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Cerebrospinal Fluid, whole blood, serum, and plasma
To assess time taken from approval by IRB to approval by internal boards for sites.
| 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. | 3 Months |
| Time from site activation to recruitment of 10 participants | Time taken from site activation to recruitment of 10 participants | 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. | 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 | 3 Months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |