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Radioactive Drug
[123I]β-CIT for Parkinson's Disease
Phase 2
Waitlist Available
Led By David Russell, MD, PhD
Research Sponsored by Institute for Neurodegenerative Disorders
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new strategy to identify people at risk for Parkinson's disease before they show any symptoms. The strategy involves combining two biomarkers of parkinsonism, olfaction and brain imaging, with a radioactively labeled drug. First-degree relatives of PD patients will be recruited to participate in this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
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
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
Estimate the frequency of olfactory loss of first-degree relatives of PD patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: [123I]β-CIT and SPECT imagingExperimental Treatment2 Interventions
To Assess [123I]β-CIT and SPECT imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[123I]β-CIT
2006
Completed Phase 2
~230
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Who is running the clinical trial?
Institute for Neurodegenerative DisordersLead Sponsor
48 Previous Clinical Trials
10,014 Total Patients Enrolled
United States Department of DefenseFED
867 Previous Clinical Trials
324,362 Total Patients Enrolled
Molecular NeuroImagingOTHER
26 Previous Clinical Trials
1,940 Total Patients Enrolled
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