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A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[123I]β-CIT and SPECT imaging

[123I]β-CIT

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson Disease, SPECT imaging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institute for Neurodegenerative Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[123I]β-CIT and SPECT imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Estimate the frequency of olfactory loss of first-degree relatives of PD patients

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

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

Full Information

NCT ID

NCT00387075

First Posted

October 10, 2006

Last Updated

March 28, 2022

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

United States Department of Defense, Molecular NeuroImaging

1. Study Identification

Unique Protocol Identification Number

NCT00387075

Brief Title

A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute for Neurodegenerative Disorders

Collaborators

United States Department of Defense, Molecular NeuroImaging

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson Disease, SPECT imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Masking Description

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

Allocation

N/A

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[123I]β-CIT and SPECT imaging

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

[123I]β-CIT and SPECT imaging

Intervention Description

Intervention Type

Drug

Intervention Name(s)

[123I]β-CIT

Intervention Description

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),

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Estimate the frequency of olfactory loss of first-degree relatives of PD patients

Time Frame

1 year

Title

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

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Russell, MD, PhD

Organizational Affiliation

Institute for Neurodegenerative Disorders

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute for Neurodegenerative Disorders

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9527140

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. doi: 10.1136/jnnp.64.3.314.

Results Reference

background

PubMed Identifier

1933245

Citation

Fearnley JM, Lees AJ. Ageing and Parkinson's disease: substantia nigra regional selectivity. Brain. 1991 Oct;114 ( Pt 5):2283-301. doi: 10.1093/brain/114.5.2283.

Results Reference

background

PubMed Identifier

14593169

Citation

DeKosky ST, Marek K. Looking backward to move forward: early detection of neurodegenerative disorders. Science. 2003 Oct 31;302(5646):830-4. doi: 10.1126/science.1090349.

Results Reference

background

PubMed Identifier

12498954

Citation

Braak H, Del Tredici K, Rub 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. doi: 10.1016/s0197-4580(02)00065-9.

Results Reference

background

PubMed Identifier

15099546

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. doi: 10.1016/S1474-4422(04)00740-9.

Results Reference

background

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A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

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