Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression (ELLDOPA)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||[123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease|
- Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.
|Study Start Date:||April 2000|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Assess [123I]B-CIT SPECT imaging
To assess[123I]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed.
Drug: [123I]B-CIT SPECT imaging
To assess [123I]B-CIT SPECT imaging
Other Name: [123I]B-CIT
All subjects will be imaged at the Institute for Neurodegenerative Disorders.
Subjects will be evaluated sequentially with [123I]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had [123I]ß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study.
Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134784
|Principal Investigator:||Kenneth L Marek, MD||Institute for Neurodegenerative Disorders|