Clinical trial NCT00387075: A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease
Official title: Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson Disease
SPECT imaging
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Molecular NeuroImaging
First posted: 2006-10-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility 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

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)
timeFrame: 1 year
Secondary outcomes:
measure: Estimate the frequency of olfactory loss of first-degree relatives of PD patients
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: David Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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