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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00096720
Enrollment
112
Registered
2004-11-15
Start date
2004-02-29
Completion date
2007-05-31
Last updated
2010-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Parkinsonian Syndrome

Keywords

parkinson, brain imaging, diagnosis

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.

Interventions

DRUGlevodopa
DRUGMirapex (pramipexole)

Sponsors

Boehringer Ingelheim
CollaboratorINDUSTRY
United States Department of Defense
CollaboratorFED
Institute for Neurodegenerative Disorders
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in outcomes from scan 1 to scan 2

Secondary

MeasureTime frame
Change in outcomes from scan 2 to scan 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026