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

September 28, 2010 updated by: Institute for Neurodegenerative Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in outcomes from scan 1 to scan 2

Secondary Outcome Measures

Outcome Measure
Change in outcomes from scan 2 to scan 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

United States Department of Defense
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 12, 2004

First Submitted That Met QC Criteria

November 12, 2004

First Posted (Estimate)

November 15, 2004

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSPECT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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