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
|Condition or disease||Intervention/treatment||Phase|
|Parkinsonian Syndrome||Drug: [123I]ß CIT and SPECT imaging||Phase 2|
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)|
|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|
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
- CIT uptake is the Specific: Nondisplaceable striatal uptake ratio [ Time Frame: 2 yrs ]
- CIT uptake measures from at-risk individuals will be compared with healthy subjects. [ Time Frame: 2 yrs ]
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|
|Principal Investigator:||Kenneth L. Marek, MD||President and Senior Scientist|