COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: N/A
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
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT00117819

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kenneth L. Marek, MD President and Senior Scientist
Layout table for additonal information
Responsible Party: Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders Identifier: NCT00117819    
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:
Layout table for MeSH terms
Parkinsonian Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders