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

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ClinicalTrials.gov Identifier: NCT00117819
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : May 2, 2014
Indiana University
Albany Medical College
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinsonian Syndrome Drug: [123I]ß CIT and SPECT imaging Phase 2

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  (Clinical Trial)
Actual Enrollment : 232 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome
Study Start Date : March 2001
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • [123I]ß CIT
  • SPECT imaging

Primary Outcome Measures :
  1. CIT uptake is the Specific: Nondisplaceable striatal uptake ratio [ Time Frame: 2 yrs ]

Secondary Outcome Measures :
  1. CIT uptake measures from at-risk individuals will be compared with healthy subjects. [ Time Frame: 2 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117819

United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Indiana University
Albany Medical College
Principal Investigator: Kenneth L. Marek, MD President and Senior Scientist

Responsible Party: Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00117819     History of Changes
Other Study ID Numbers: At-Risk
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Kenneth Marek, MD, Institute for Neurodegenerative Disorders:
family history

Additional relevant MeSH terms:
Pathologic Processes