NCT00387075

A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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	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),

Timeline

• Start date: 2006-11-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2006-10-12
• Last updated: 2022-03-29

Locations

1 site across 1 country: United States