A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2023-08-31

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Participants and Investigators were not provided results of the University of Pennsylvania Smell Identification Test (UPSIT).

Study Groups

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[123I]β-CIT and SPECT imaging

To Assess \[123I\]β-CIT and SPECT imaging

Group Type EXPERIMENTAL

[123I]β-CIT and SPECT imaging

Intervention Type PROCEDURE

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

Intervention Type DRUG

SPECT 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),

Interventions

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[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.

Intervention Type PROCEDURE

[123I]β-CIT

SPECT 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),

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes