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Sponsors and Collaborators: |
Institute for Neurodegenerative Disorders Indiana University Albany Medical College |
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Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00117819 |
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 | Intervention | Phase |
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Parkinsonian Syndrome |
Procedure: [123I]ß CIT and SPECT imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome |
Estimated Enrollment: | 350 |
Study Start Date: | March 2001 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Procedure: [123I]ß CIT and SPECT imaging
1473 WIRB: Dynamic SPECT Imaging with [123I]ß-CIT in Healthy Controls and Individuals at Risk for Parkinsonism due to Family History of Parkinsonism or Exposure to an Environmental Toxin Potentially Associated with Parkinsonism
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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.
Ages Eligible for Study: | 22 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Institute for Neurodegenerative Disorders | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Kenneth L. Marek, MD | President and Senior Scientist |
Responsible Party: | Institute for Neurodegenerative Disorders ( Danna L. Jennings, MD ) |
Study ID Numbers: | At-Risk |
Study First Received: | June 30, 2005 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00117819 |
Health Authority: | United States: Food and Drug Administration |
parkinson family history diagnosis |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Brain Diseases |
Pathologic Processes Disease Syndrome Nervous System Diseases |