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

Not Applicable

Completed

• Conditions: Parkinson Disease; Parkinsonian Syndrome

• Registration Number: NCT00129181
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief Summary

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.

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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-08-09
• Study First Submitted QC: 2005-08-09
• Study First Posted: 2005-08-11
• Primary Completion: 2006-12
• Study Completion: 2007-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-27
• Last Update Posted: 2009-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease	1 year

Secondary Outcome Measures

Name	Time	Method
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	2 years
To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease	1 year

Trial Locations

Locations (9)

Dept. of Neurology, University of Leipzig; 🇩🇪 Leipzig, Germany

Department of Neurological Sciences-University of Napoli; 🇮🇹 Naples, Italy

Dept. of Neurology Marburg, Phillips-Univ.; 🇩🇪 Marburg, Germany

Ambulanz für Bewegungsstörungen, Neurologische Poliklinik; 🇩🇪 München, Germany

University of Catania-Department of Neurosciences; 🇮🇹 Catania, Italy

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Parkinson Institute Milan; 🇮🇹 Milan, Italy

Department of Neurology, Innsbruck Medical University; 🇦🇹 Innsbruck, Austria

Neurological Department, Wilhelminenspital; 🇦🇹 Vienna, Austria