FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

Parkinson Disease Clinical Trial

— SAVE001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170063
• Other study ID #: SAVE001
• Status: Completed
• Start date: August 8, 2017
• Est. completion date: March 12, 2018

Study information

• Verified date: August 2018
• Source: Michael J. Fox Foundation for Parkinson's Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Procedure/Surgery: Biofluid samplings
Biofluid samplings (blood and cerebrospinal fluid (CSF))

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Michael J. Fox Foundation for Parkinson's Research	ICON Clinical Research Limited, Indiana University, University Health Network, Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oligomeric and PS129 a-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	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
Secondary	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
Secondary	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
Secondary	Time from site activation to recruitment of 10 participants	Time taken from site activation to recruitment of 10 participants	3 Months
Secondary	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
Secondary	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