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

Phase 2

Completed

• Conditions: Parkinson Disease; Parkinsonian Syndrome

• Registration Number: NCT00096720
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-11-12
• Study First Submitted QC: 2004-11-12
• Study First Posted: 2004-11-15
• Status Verified: 2007-05
• Study Completion: 2007-05
• Last Update Submitted: 2010-09-28
• Last Update Posted: 2010-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in outcomes from scan 1 to scan 2

Secondary Outcome Measures

Name	Time	Method
Change in outcomes from scan 2 to scan 3

Trial Locations

Locations (13)

Northwestern University; 🇺🇸 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

RUSH University Medical Center; 🇺🇸 Chicago, Illinois, United States

Colorado Neurology, PC; 🇺🇸 Englewood, Colorado, United States

Pacific Neuroscience Medical Group; 🇺🇸 Oxnard, California, United States

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States

University of Florida Movement Disorders Center; 🇺🇸 Gainesville, Florida, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

NeuroHealth, Inc.; 🇺🇸 Warwick, Rhode Island, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States