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Diagnostic and Prognostic Biomarkers in Parkinson Disease (PROBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653783
Recruitment Status : Unknown
Verified December 2008 by The Parkinson Study Group.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2008
Last Update Posted : December 31, 2008
United States Department of Defense
Information provided by:
The Parkinson Study Group

Brief Summary:
The overall goal of PROBE is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of PD.

Condition or disease
Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy

Detailed Description:

PROBE will test three biomarkers in PD subjects and controls to determine their feasibility and potential utility as markers of risk and prognosis for PD. This is a case control study, in which PD subjects will be compared to neurologically healthy controls and disease controls (MSA and PSP). The blood biomarker samples will be drawn once to evaluate blood alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. Olfaction will be measured using the UPSIT for all subjects. The UPSIT will be conducted as part of PostCEPT for PD subjects and will only be repeated in this study for PD subjects in not done within 6 months. Control subjects may also choose to submit a blood specimen for processing and storage at the Coriell Institute for Medical Research, a research resource supported by the NINDS Human Genetics Resource Center.

Follow-up of the PD population over a 3-year period will allow us to evaluate the prognosis for important motor aspects of PD that will occur frequently in this cohort. These complications of PD include motor complications, postural instability, and non-motor impairment such as cognitive decline.

Healthy and disease control subjects may give permission at the Baseline visit to be contacted and followed in the previously established PSG FOUND study using mail and telephone contact to assess clinical status. Participation in the FOUND study provides another mechanism to maintain contact with subjects and collect supplemental data beyond that collected at the PROBE Baseline visit.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease
Study Start Date : August 2007
Estimated Primary Completion Date : July 2008

Primary Outcome Measures :
  1. α-synuclein, transcriptomic profiles and olfactory function [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Three Years ]
  2. University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Three Years ]

Biospecimen Retention:   Samples With DNA
Whole Blood, serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, spouses, PD patients from another trial

Parkinson Disease Inclusion Criteria:

  • Subject is participating in PostCEPT and meets UK brain bank criteria for PD
  • Willing and able to provide informed consent

Healthy Control Inclusion Criteria:

  • Spouse or non blood relative of the PD subject
  • No known current diagnosis or history of a neurological disease
  • MMSE score >27
  • Age >45
  • Willing and able to provide informed consent

Parkinsonism/Disease Control Inclusion Criteria (MSA and PSP)

  • A diagnosis of Probable MSA based on Consensus Criteria OR Probable PSP based on NINDS-PSP Criteria
  • Willing and able to provide informed consent

Exclusion Criteria for All Groups:

  • Current use (within 7 days prior to Baseline Visit) of anticoagulants (e.g., warfarin or heparin)
  • Known bleeding disorder (acquired or inherited)
  • Known blood disorder (e.g. leukemia) or a history of anemia with a documented hematocrit <30
  • Known pregnancy
  • History of nasal trauma, sinusitis, or other nasal pathology that would interfere with smell testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00653783

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United States, New York
Parkinson Study Group
Rochester, New York, United States
Sponsors and Collaborators
The Parkinson Study Group
United States Department of Defense
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Principal Investigator: Bernard Ravina, MD University of Rochester
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Responsible Party: Bernard Ravina, MD, MSCE, Principal Investigator, University of Rochester, Clinical Trials Coordination Center Identifier: NCT00653783    
Other Study ID Numbers: U01NS050095-02_PROBE
DOD Grant # W81XWH-07-1-0007
NINDS Grant 5 U01 NS050095-02
U01NS050095-02 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008
Keywords provided by The Parkinson Study Group:
Parkinson disease
Multiple System Atrophy
Progressive Supranuclear Palsy
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Neurologic Manifestations
Eye Diseases