FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

Description

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 Start Date

August, 08 2017

Estimated Completion Date

December 2017

Interventions

  • Procedure: Procedure/Surgery: Biofluid samplings

Study ID

Michael J. Fox Foundation for Parkinson's Research -- SAVE001

Status

Recruiting

Trial ID

NCT03170063

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

50

Sponsor

Michael J. Fox Foundation for Parkinson's Research

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)

Gender

All

Ages

30 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (14)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Althea Silver 617-667-9885 asilver2@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Althea Silver 617-667-9885 asilver2@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Althea Silver 617-667-9885 asilver2@bidmc.harvard.edu
University of Pennsylvania - Philadelphia, Pennsylvania 269.5 miles Rachael Purri 215-829-6952 rachael.purri@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 269.5 miles Rachael Purri 215-829-6952 rachael.purri@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 269.5 miles Rachael Purri 215-829-6952 rachael.purri@uphs.upenn.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Christine Hunter RN 713-798-3951 chunter@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Christine Hunter RN 713-798-3951 chunter@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Christine Hunter RN 713-798-3951 chunter@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Christine Hunter RN 713-798-3951 chunter@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Christine Hunter RN 713-798-3951 chunter@bcm.edu
Oregon Health and Sciences University - Portland, Oregon 2,538.3 miles Alison Freed 503-494-1382 freeal@ohsu.edu
Oregon Health and Sciences University - Portland, Oregon 2,538.3 miles Alison Freed 503-494-1382 freeal@ohsu.edu
Oregon Health and Sciences University - Portland, Oregon 2,538.3 miles Alison Freed 503-494-1382 freeal@ohsu.edu

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