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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: ClinicalTrials.gov
Last refreshed on: 4 April 2022
Main ID:  NCT00387075
Date of registration: 10/10/2006
Prospective Registration: Yes
Primary sponsor: Institute for Neurodegenerative Disorders
Public title: A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease
Scientific title: Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease
Date of first enrolment: November 2006
Target sample size: 3000
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT00387075
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     David Russell, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Institute for Neurodegenerative Disorders
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: [123I]ß-CIT
Procedure: [123I]ß-CIT and SPECT imaging
Primary Outcome(s)
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 Outcome(s)
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]
Estimate the frequency of olfactory loss of first-degree relatives of PD patients [Time Frame: 1 year]
Secondary ID(s)
PARS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Molecular NeuroImaging
United States Department of Defense
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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