Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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4 April 2022 |
Main ID: |
NCT00387075 |
Date of registration:
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10/10/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease
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Scientific title:
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Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease |
Date of first enrolment:
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November 2006 |
Target sample size:
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3000 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT00387075 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David Russell, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Institute for Neurodegenerative Disorders |
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Key inclusion & exclusion criteria
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At Risk - Inclusion Criteria:
- subject must have a first-degree relative with PD, based on their report
- subject must not carry a diagnosis of PD or other neurodegenerative disorder.
- subject must be either at least 50 yrs old or within 10 yrs of the age of onset of
their affected relative
- Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma,
sinus infection, sinus surgery)
- Subject must not be pregnant if participating in the imaging portion of this study
Non-First Degree Relative - Inclusion Criteria:
- Subject must not carry a diagnosis of PD or other neurodegenerative disorders
- Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma,
sinus infection, sinus surgery)
- Subject must not be pregnant or be an actively nursing mother if participating in the
imaging portion of this study.
Exclusion Criteria:
- diagnosis of PD or other neurodegenerative disorder
- other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus
surgery)
- pregnancy, if participating in the imaging portion of this study
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: [123I]ß-CIT
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Procedure: [123I]ß-CIT and SPECT imaging
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Primary Outcome(s)
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the mean striatal uptake of [123I]B-CIT in first-degree relatives with a loss of odor identification, compared to an established healthy control database (age 40-70; n=50)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Compare striatal DAT imaging in first-degree relatives of PD patients without signs or symptoms of PD with olfactory loss to age matched healthy controls
[Time Frame: 1 year]
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Determine if a reduction in DAT density using [123I]B-CIT and SPECT imaging in first-degree relatives of PD patients without signs or symptoms of PD at baseline predicts the onset of clinical PD at 2-year follow-up
[Time Frame: 1 year]
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Estimate the frequency of olfactory loss of first-degree relatives of PD patients
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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