FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

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

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)