A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease

April 9, 2014 updated by: Kenneth Marek, MD, Institute for Neurodegenerative Disorders

Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome

This study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. Participants will have brain imaging to assess dopamine transporter density. The imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Participants may be contacted to repeat these procedures every 12 to 18 months.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 22 years or older
  • A clinical diagnosis of Parkinson's disease (PD), positive family history of PD and/or potential exposure to environmental toxins
  • Normal screening laboratory studies

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [123I]ß CIT and SPECT imaging
To assess [123I]ß-CIT and SPECT imaging
Drug: [123I]ß CIT and SPECT imaging
To assess [123I]ß CIT and SPECT imaging
Other Names:
  • SPECT imaging
  • [123I]ß CIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
Time Frame: 2 yrs
2 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
CIT uptake measures from at-risk individuals will be compared with healthy subjects.
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

Indiana University
Albany Medical College

Investigators

  • Principal Investigator: Kenneth L. Marek, MD, President and Senior Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 8, 2005

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • At-Risk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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