NCT03170063

FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Michael J. Fox Foundation for Parkinson's Research · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Procedure/Surgery: Biofluid samplings	Biofluid samplings (blood and cerebrospinal fluid (CSF))

Timeline

• Start date: 2017-08-08
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-05-30
• Last updated: 2018-08-20

Locations

5 sites across 1 country: United States