- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653783
Diagnostic and Prognostic Biomarkers in Parkinson Disease (PROBE)
Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States
- Parkinson Study Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
α-synuclein, transcriptomic profiles and olfactory function
Time Frame: Three years
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Three years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Unified Parkinson Disease Rating Scale (UPDRS)
Time Frame: Three Years
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Three Years
|
University of Pennsylvania Smell Identification Test (UPSIT)
Time Frame: Three Years
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Three Years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Tauopathies
- Cranial Nerve Diseases
- Autonomic Nervous System Diseases
- Ocular Motility Disorders
- Paralysis
- Primary Dysautonomias
- Hypotension
- Ophthalmoplegia
- Parkinson Disease
- Atrophy
- Multiple System Atrophy
- Shy-Drager Syndrome
- Supranuclear Palsy, Progressive
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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