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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
GE Healthcare
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00129181
First received: August 9, 2005
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Parkinson Disease
Parkinsonian Syndrome
Drug: cabergoline
Drug: carbidopa/levodopa
Procedure: DATscan and SPECT imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cabergoline
    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).
    Drug: carbidopa/levodopa
    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).
    Procedure: DATscan and SPECT imaging
    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).
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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129181

Locations
Austria
Department of Neurology, Innsbruck Medical University
Innsbruck, Austria, 6020
Neurological Department, Wilhelminenspital
Vienna, Austria, 1160
Germany
Dept. of Neurology, University of Leipzig
Leipzig, Germany, 04103
Dept. of Neurology Marburg, Phillips-Univ.
Marburg, Germany, 35039
Ambulanz für Bewegungsstörungen, Neurologische Poliklinik
München, Germany, 81377
Italy
University of Catania-Department of Neurosciences
Catania, Italy, 95123
Parkinson Institute Milan
Milan, Italy
Department of Neurological Sciences-University of Napoli
Naples, Italy, 80131
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Pfizer
GE Healthcare
Investigators
Principal Investigator: Kenneth L Marek, MD The Institute for Neurodegenerative Disorders
Principal Investigator: John P Seibyl, MD The Institute for Neurodegenerative Disorders
  More Information

Publications:
Parkinson Study Group. Does levodopa slow or hasten the rate of progression of Parkinson's disease? The results of the ELLDOPA trial. Neurology 2003; 60(5) Suppl1: A80-A81.

ClinicalTrials.gov Identifier: NCT00129181     History of Changes
Other Study ID Numbers: AMAD001
Study First Received: August 9, 2005
Last Updated: August 27, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
brain imaging
diagnosis

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Cabergoline
Carbidopa
Carbidopa, levodopa drug combination
Levodopa
Adjuvants, Immunologic
Anti-Dyskinesia Agents
Antineoplastic Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014