A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

• 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
• 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)

Procedure: [123I]ß-CIT and SPECT imaging

Drug: [123I]ß-CIT

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)

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]

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]

Secondary ID(s)

PARS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense

Molecular NeuroImaging