Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

Study Overview
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Brief Summary
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Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

Detailed Description
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Brain imaging will be conducted three times during this study. Study participants will travel to IND for [123I]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for [123I]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final [123I]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of [123I]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.

Official Title
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Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's

Conditions
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Parkinson Disease, Parkinsonian Syndrome

Intervention / Treatment
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* Drug: levodopa
* Drug: Mirapex (pramipexole)
* Procedure: [123I]ß-CIT and SPECT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 years or older at time of Parkinson Disease (PD) diagnosis clinical diagnosis of PD of equal to or less than 7.5 years Normal laboratory screening Exclusion Criteria: Participant is pregnant Participant has atypical or drug induced PD Participant has significant dementia

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levodopa|nan|
|Drug: Mirapex (pramipexole)|nan|
|Procedure: [123I]ß-CIT and SPECT imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in outcomes from scan 1 to scan 2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in outcomes from scan 2 to scan 3 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson, brain imaging, diagnosis