Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatments [123i]β-cit and spect imaging, [123i]β-cit
Phase phase 2
Sponsor Institute for Neurodegenerative Disorders
Collaborator United States Department of Defense
Start date November 2006
End date November 2017
Trial size 3000 participants
Trial identifier NCT00387075, PARS

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose diagnostic
Arm
(Experimental)
To Assess [123I]β-CIT and SPECT imaging
[123i]β-cit and spect imaging
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.
[123i]β-cit
PECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections),

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Estimate the frequency of olfactory loss of first-degree relatives of PD patients
time frame: 1 year
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
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

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease
Principal investigator Danna Jennings, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Neurodegenerative Disorders.