Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

August 27, 2009 updated by: Institute for Neurodegenerative Disorders

A Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's Disease

This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, open-label study of short-term treatment with levodopa or cabergoline on striatal DATscan uptake in early Parkinson's disease. Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Austria
      • Innsbruck, Austria, 6020
        • Department of Neurology, Innsbruck Medical University
      • Vienna, Austria, 1160
        • Neurological Department, Wilhelminenspital
  • Germany
      • Leipzig, Germany, 04103
        • Dept. of Neurology, University of Leipzig
      • Marburg, Germany, 35039
        • Dept. of Neurology Marburg, Phillips-Univ.
      • München, Germany, 81377
        • Ambulanz für Bewegungsstörungen, Neurologische Poliklinik
  • Italy
      • Catania, Italy, 95123
        • University of Catania-Department of Neurosciences
      • Milan, Italy
        • Parkinson Institute Milan
      • Naples, Italy, 80131
        • Department of Neurological Sciences-University of Napoli
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is aged 40 years or older.
  • Written informed consent is obtained.
  • Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
  • Hoehn and Yahr stages for subjects are I-II.

Exclusion Criteria:

  • The subject has atypical or drug-induced Parkinson's disease.
  • The subject has dementia.
  • The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  • The subject is pregnant.

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: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease
Time Frame: 1 year
1 year
To further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

GE Healthcare
Pfizer

Investigators

  • Principal Investigator: Kenneth L Marek, MD, The Institute for Neurodegenerative Disorders
  • Principal Investigator: John P Seibyl, MD, The Institute for Neurodegenerative Disorders

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

January 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 9, 2005

First Submitted That Met QC Criteria

August 9, 2005

First Posted (Estimate)

August 11, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMAD001

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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