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NCT Number: NCT00096720

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Parkinsonian Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pacific Neuroscience Medical Group, Oxnard, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levodopa

Drug

Mirapex (pramipexole)

Drug

[123I]ß-CIT and SPECT imaging

Procedure

Primary outcomes

  1. Change in outcomes from scan 1 to scan 2

Secondary outcomes

  1. Change in outcomes from scan 2 to scan 3

Sponsors and collaborators

Lead sponsor

Institute for Neurodegenerative Disorders

Other

Collaborators

  • Boehringer Ingelheim
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Nov 15, 2004
Registry last updated
Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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