A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Procedure: [123I]B-CIT injection and SPECT imaging Drug: none established |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease |
- 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 ] [ Designated as safety issue: Yes ]
- Estimate the frequency of olfactory loss of first-degree relatives of PD patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Assess [123I]β-CIT and brain imaging |
Procedure: [123I]B-CIT injection 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: none established
PECT 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),
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- subject must have a first-degree relative with PD, based on their report
- subject must be either at least 50 yrs old or within 10 yrs of the age of onset of their affected relative
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
Contacts and Locations| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Danna Jennings, MD | Institute for Neurodegenerative Disorders |
More Information
Publications:
| Responsible Party: | Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT00387075 History of Changes |
| Other Study ID Numbers: | PARS |
| Study First Received: | October 10, 2006 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Institute for Neurodegenerative Disorders:
|
Parkinson Disease SPECT imaging |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013