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

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00096720
First received: November 12, 2004
Last updated: September 28, 2010
Last verified: May 2007

November 12, 2004
September 28, 2010
February 2004
Not Provided
Change in outcomes from scan 1 to scan 2
Same as current
Complete list of historical versions of study NCT00096720 on ClinicalTrials.gov Archive Site
Change in outcomes from scan 2 to scan 3
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
  • Parkinson Disease
  • Parkinsonian Syndrome
  • Drug: levodopa
  • Drug: Mirapex (pramipexole)
  • Procedure: [123I]ß-CIT and SPECT imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
May 2007
Not Provided

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096720
INSPECT
No
Danna Jennings M.D., Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
  • Boehringer Ingelheim
  • Department of Defense
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP