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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096720
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : September 29, 2010
Boehringer Ingelheim
United States Department of Defense
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinsonian Syndrome Drug: levodopa Drug: Mirapex (pramipexole) Procedure: [123I]ß-CIT and SPECT imaging Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's
Study Start Date : February 2004
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in outcomes from scan 1 to scan 2

Secondary Outcome Measures :
  1. Change in outcomes from scan 2 to scan 3

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096720

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United States, California
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
United States, Colorado
Colorado Neurology, PC
Englewood, Colorado, United States, 80113
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida Movement Disorders Center
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, New York
Parkinson's Disease and Movement Disorders Center of Albany Medical College
Albany, New York, United States, 12205
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
NeuroHealth, Inc.
Warwick, Rhode Island, United States, 02886
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Boehringer Ingelheim
United States Department of Defense
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Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders

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Responsible Party: Danna Jennings M.D., Institute for Neurodegenerative Disorders Identifier: NCT00096720    
Other Study ID Numbers: INSPECT
First Posted: November 15, 2004    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: May 2007
Keywords provided by Institute for Neurodegenerative Disorders:
brain imaging
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Dopamine Agonists