A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
United States Department of Defense
Molecular NeuroImaging
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00387075
First received: October 10, 2006
Last updated: July 12, 2016
Last verified: July 2016

October 10, 2006
July 12, 2016
November 2006
November 2017   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
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)
Complete list of historical versions of study NCT00387075 on ClinicalTrials.gov Archive Site
  • Estimate the frequency of olfactory loss of first-degree relatives of PD patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Estimate the frequency of olfactory loss of first-degree relatives of PD patients
  • 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]-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
Not Provided
Not Provided
 
A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease
Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease
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.
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Parkinson Disease
  • Procedure: [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.
  • Drug: [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),
Experimental: [123I]β-CIT and SPECT imaging
To Assess [123I]β-CIT and SPECT imaging
Interventions:
  • Procedure: [123I]β-CIT and SPECT imaging
  • Drug: [123I]β-CIT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
November 2017
November 2017   (final data collection date for primary outcome measure)

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
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387075
PARS
No
Not Provided
Not Provided
Danna Jennings, MD, Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
  • United States Department of Defense
  • Molecular NeuroImaging
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP