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

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

The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Procedure/Surgery: Biofluid samplings

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

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612-3863
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's Disease Subjects; Up to 30 Parkinson's Disease patients will be enrolled.	Procedure: Procedure/Surgery: Biofluid samplings; Biofluid samplings (blood and cerebrospinal fluid (CSF))
Healthy Controls; Up to 20 healthy controls will be enrolled.	Procedure: Procedure/Surgery: Biofluid samplings; Biofluid samplings (blood and cerebrospinal fluid (CSF))

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michael J. Fox Foundation for Parkinson's Research
• Collaborators: University Health Network, Toronto; Indiana University; ICON Clinical Research Limited
• Investigators: Principal Investigator: Connie Marras, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Biomarker; Parkinson's Disease; Alpha-Synuclein
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: SAVE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No