FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) (SAVE001)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Procedure/Surgery: Biofluid samplings


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's Disease Subjects<br>Up to 30 Parkinson's Disease patients will be enrolled. | Procedure: Procedure/Surgery: Biofluid samplings<br>* Biofluid samplings (blood and cerebrospinal fluid (CSF))<br>|
| Healthy Controls<br>Up to 20 healthy controls will be enrolled. | Procedure: Procedure/Surgery: Biofluid samplings<br>* Biofluid samplings (blood and cerebrospinal fluid (CSF))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Alpha-Synuclein, Biomarker