A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Phase 2

• Conditions: Parkinson Disease
• Interventions: Procedure: [123I]β-CIT and SPECT imaging; Drug: [123I]β-CIT

• Registration Number: NCT00387075
• Lead Sponsor: Institute for Neurodegenerative Disorders

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.

Study Timeline

• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-12
• Study Start: 2006-11
• Status Verified: 2019-04
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)	1 year

Secondary Outcome Measures

Name	Time	Method
Estimate the frequency of olfactory loss of first-degree relatives of PD patients	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	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	1 year

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States