Parkinson Disease
Conditions
Keywords
Parkinson's Disease, Alpha-Synuclein, Biomarker
Brief 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.
Detailed description
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
Interventions
PROCEDUREProcedure/Surgery: Biofluid samplings
Biofluid samplings (blood and cerebrospinal fluid (CSF))
Sponsors
University Health Network, Toronto
Indiana University
ICON Clinical Research Limited
Michael J. Fox Foundation for Parkinson's Research
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oligomeric and PS129 α-syn levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from central IRB approval to site approval (for those sites requiring administrative review) | 3 Months | To assess time taken from approval by IRB to approval by internal boards for sites. |
| Time from site selection to contract full execution | 3 Months | 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. |
| Time from IRB submission to approval by central IRB | 3 Months | To assess time taken from submission of proposal to IRB to approval by the IRB |
| Proportion of samples conforming to collection, processing and shipping protocols. | 3 Months | To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols. |
| Proportion of participants agreeing to be contacted for future Fox BioNet protocols | 3 Months | To gauge the willingness of participants to participate in subsequent Fox BioNet studies |
| Time from site activation to recruitment of 10 participants | 3 Months | Time taken from site activation to recruitment of 10 participants |
Countries
United States
Outcome results
None listed