Diagnostic and Prognostic Biomarkers in Parkinson Disease (PROBE)
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| ClinicalTrials.gov Identifier: NCT00653783 |
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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
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| Condition or disease |
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| Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy |
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.
| 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 |
- α-synuclein, transcriptomic profiles and olfactory function [ Time Frame: Three years ]
- Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Three Years ]
- University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Three Years ]
Biospecimen Retention: Samples With DNA
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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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT00653783
| United States, New York | |
| Parkinson Study Group | |
| Rochester, New York, United States | |
| Principal Investigator: | Bernard Ravina, MD | University of Rochester |
| 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 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:
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Parkinson disease Multiple System Atrophy MSA Progressive Supranuclear Palsy |
PSP observational biomarker |
Additional relevant MeSH terms:
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Multiple System Atrophy Shy-Drager Syndrome Parkinson Disease Atrophy Supranuclear Palsy, Progressive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical |
Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Paralysis Neurologic Manifestations Eye Diseases Signs and Symptoms Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases Cardiovascular Diseases |