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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
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.
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.
Age
30 - No limit years
Sex
ALL
Healthy Volunteers
No
Pacific Neuroscience Medical Group
Oxnard, California, United States
Colorado Neurology, PC
Englewood, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
University of Florida Movement Disorders Center
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
RUSH University Medical Center
Chicago, Illinois, United States
Boston University Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Parkinson's Disease and Movement Disorders Center of Albany Medical College
Albany, New York, United States
Duke University
Durham, North Carolina, United States
Start Date
February 1, 2004
Completion Date
May 1, 2007
Last Updated
September 29, 2010
112
ACTUAL participants
levodopa
DRUG
Mirapex (pramipexole)
DRUG
[123I]ß-CIT and SPECT imaging
PROCEDURE
Lead Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06113640