Diagnostic and Prognostic Biomarkers in Parkinson Disease (PROBE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by The Parkinson Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
The Parkinson Study Group
ClinicalTrials.gov Identifier:
NCT00653783
First received: April 2, 2008
Last updated: December 30, 2008
Last verified: December 2008
  Purpose

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
Parkinson Disease
Multiple System Atrophy
Progressive Supranuclear Palsy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Parkinson Study Group:

Primary Outcome Measures:
  • α-synuclein, transcriptomic profiles and olfactory function [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Three Years ] [ Designated as safety issue: No ]
  • University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Three Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood, serum


Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, spouses, PD patients from another trial

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653783

Locations
United States, New York
Parkinson Study Group
Rochester, New York, United States
Sponsors and Collaborators
The Parkinson Study Group
Investigators
Principal Investigator: Bernard Ravina, MD University of Rochester
  More Information

No publications provided

Responsible Party: Bernard Ravina, MD, MSCE, Principal Investigator, University of Rochester, Clinical Trials Coordination Center
ClinicalTrials.gov Identifier: NCT00653783     History of Changes
Other Study ID Numbers: U01NS050095-02_PROBE, DOD Grant # W81XWH-07-1-0007, NINDS Grant 5 U01 NS050095-02
Study First Received: April 2, 2008
Last Updated: December 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Parkinson Study Group:
Parkinson disease
Multiple System Atrophy
MSA
Progressive Supranuclear Palsy
PSP
observational
biomarker

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Central Nervous System Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Parkinson Disease
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014