FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

Completed

Conditions studied: Parkinson Disease

In brief

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

Key facts

Study ID

NCT03170063

Run by

Michael J. Fox Foundation for Parkinson's Research

People needed

54

Starts

2017-08-08

Expected to finish

2018-03-12

Last updated by the study team

2018-08-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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