FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

NCT03170063 | Completed

• 1 other identifier: SAVE001
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Alpha-Synuclein; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time from IRB submission to approval by central IRB

  3 Months

• Time from central IRB approval to site approval (for those sites requiring administrative review)

  3 Months

• Time from site selection to contract full execution

  3 Months

• Time from site activation to recruitment of 10 participants

  3 Months

• Proportion of samples conforming to collection, processing and shipping protocols.

  3 Months

Study Arms (2)

Parkinson's Disease Subjects

Up to 30 Parkinson's Disease patients will be enrolled.

Procedure: Procedure/Surgery: Biofluid samplings

Healthy Controls

Up to 20 healthy controls will be enrolled.

Procedure: Procedure/Surgery: Biofluid samplings

Interventions

Procedure/Surgery: Biofluid samplings PROCEDURE

Biofluid samplings (blood and cerebrospinal fluid (CSF))

Healthy Controls; Parkinson's Disease Subjects

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead
• University Health Network, Toronto: collaborator
• Indiana University: collaborator
• ICON Clinical Research Limited: collaborator

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612-3863, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal Fluid, whole blood, serum, and plasma

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Connie Marras, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist at Toronto Western Hospital Movement Disorders Centre

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 30, 2017
• Study Start: August 8, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)