The purpose of this project is to assess the change in dopamine transporter density in Parkinson’s disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT imaging, a marker of dopamine terminal integrity and of clinical disease state.

Condition	Intervention	Phase
Parkinson''''s Disease	Procedure: [123I]ß CIT and SPECT imaging	Phase II

Further Study Details: 

Primary Outcomes: To assess the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson’s disease patients.
Secondary Outcomes: - To assess the effect of levodopa treatment on the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson’s disease patients.; 2) To determine whether the rate of reduction in 123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with the dopamine transporter density measured in the first scan. Is the rate of progression in early Parkinson�; 3) To determine whether the rate of reduction in [123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with changes in the clinical measures of severity of disease.; 4) To determine cognitive changes in Parkinson’s Disease and correlate those changes with objective imaging measures of dopaminergic degeneration.
Expected Total Enrollment:  150

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, nine, eighteen and thirty-six months following the start of their participation in the ELLDOPA study. In this extension study the subjects will receive two additional scans, at forty-eight months and at sixty months 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.

Ages Eligible for Study:  22 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson''''s Disease Progression (DAMD17-99-1-9472) [ [123I] B-CIT And Spect In Vivo Imaging Assessment Of Dopamine Transporter Density In Subjects With Early Parkinson’s Disease Participating In Earlier Vs. Later Levodopa In Parkinson''''s Disease (ELLDOPA)].

Exclusion Criteria:

• Inability to sign informed consent and participate in all study procedures.
• Minimental status exam < 25.
• Pregnancy

Study chairs or principal investigators

Kenneth L Marek, MD,  Principal Investigator,  Institute for Neurodegenerative Disorders   

Study ID Numbers:  Elldopa
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00134784
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13