Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT00129181 |
Recruitment Status :
Completed
First Posted : August 11, 2005
Last Update Posted : August 28, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease Parkinsonian Syndrome | Drug: cabergoline Drug: carbidopa/levodopa Procedure: DATscan and SPECT imaging | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | January 2007 |

- 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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
- To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease [ Time Frame: 1 year ]
- To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease [ Time Frame: 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 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00129181
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 |
Principal Investigator: | Kenneth L Marek, MD | The Institute for Neurodegenerative Disorders | |
Principal Investigator: | John P Seibyl, MD | The Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00129181 |
Other Study ID Numbers: |
AMAD001 |
First Posted: | August 11, 2005 Key Record Dates |
Last Update Posted: | August 28, 2009 |
Last Verified: | August 2009 |
parkinson brain imaging diagnosis |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Levodopa Carbidopa Cabergoline |
Carbidopa, levodopa drug combination Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Dopamine Agonists Adjuvants, Immunologic Immunologic Factors |