A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00387075
• Other study ID #: PARS
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2006
• Est. completion date: August 2023

Study information

• Verified date: April 2019
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• [123I]ß-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]ß-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]ß-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),

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders	Molecular NeuroImaging, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (5)

Braak H, Del Tredici K, Rüb U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. — View Citation

DeKosky ST, Marek K. Looking backward to move forward: early detection of neurodegenerative disorders. Science. 2003 Oct 31;302(5646):830-4. Review. — View Citation

Fearnley JM, Lees AJ. Ageing and Parkinson's disease: substantia nigra regional selectivity. Brain. 1991 Oct;114 ( Pt 5):2283-301. — View Citation

Lang AE, Obeso JA. Challenges in Parkinson's disease: restoration of the nigrostriatal dopamine system is not enough. Lancet Neurol. 2004 May;3(5):309-16. Review. — View Citation

Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimate the frequency of olfactory loss of first-degree relatives of PD patients		1 year
Secondary	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
Secondary	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