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A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease - NCT00387075-06510(Clinical Trial 152737)



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City:  New Haven
State:  
CT
Zip Code: 06510
Conditions: Parkinson Disease
Purpose: This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of PD will be recruited through PD research sites and national foundations to participate in this study. In addition, first degree relatives of PD patients will be recruited directly through advertising.
Study summary: First-degree relatives that agree to participate (n=3,000) will be asked to complete a 40-item olfactory identification test provided by mail. 300 subjects (225 with decreased odor identification and 75 with normal olfaction) will be invited to undergo DAT imaging at the Institute for Neurodegenerative Disorders in New Haven, CT. There will also be additional clinical follow-up at participant's clinical (local) site. The primary outcome measure for the study will be the mean striatal uptake of [123I]B-CIT in first-degree relatives with a loss of odor identification, which will be compared to an established healthy control database (age 40-70; n=50). 300 relatives will be followed longitudinally with clinical evaluations and a second imaging study completed after two years. Comparing the first and second scans in this subset of subjects will allow us to evaluate the rate of progressive loss in dopamine transporter density during this pre-symptomatic period.
Criteria: Inclusion Criteria: - subject must have a first-degree relative with PD, based on their report - subject must be either at least 50 yrs old or within 10 yrs of the age of onset of their affected relative 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
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Data Source: ClinicalTrials.gov
Date Processed: October 7, 2010
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