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Sponsors and Collaborators: |
Dresden University of Technology Pfizer |
Information provided by: | Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT00153972 |
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa.
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum.
Condition | Intervention | Phase |
Parkinson's Disease |
Drug: Cabergoline Drug: Levodopa |
Phase IV |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
MedlinePlus related topics: | Parkinson's Disease |
ChemIDplus related topics: | Dopamine Dopamine hydrochloride Levodopa Cabergoline Cabergoline diphosphate |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease |
Estimated Enrollment: | 40 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | August 2007 |
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa. This study is an investigator-blinded, randomized mono-center controlled phase IV study.
The main inclusion criteria are:
- Early (de novo) Parkinson's disease (Hoen & Yahr I and II), according to the UK brain bank criteria
The main exclusion criteria are:
Methods:
Study medication:
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heinz Reichmann, MD | ++49-351-458-0 ext 3565 | heinz.reichmann@uniklinikum-dresden.de |
Contact: Alexander Storch, MD | ++49-351-458-0 ext 2532 | alexander.storch@neuro.med.tu-dresden.de |
Germany, Saxony | |||||
Department of Neurology at the Technical University of Dresden | Recruiting | ||||
Dresden, Saxony, Germany, 01307 | |||||
Contact: Alexander Storch, MD ++49-351-458-0 ext 2532 alexander.storch@neuro.med.tu-dresden.de | |||||
Contact: Martin Wolz, MD ++49-351-458-0 ext 3886 martin.wolz@neuro.med.tu-dresden.de | |||||
Sub-Investigator: Martin Wolz, MD | |||||
Sub-Investigator: Alexander Storch, MD | |||||
Principal Investigator: Heinz Reichmann, MD | |||||
Department of Nuclear Medicine at the Technical University of Dresden | Recruiting | ||||
Dresden, Saxony, Germany, 01307 | |||||
Contact: Joerg Kotzerke, MD ++ 49-351-458-0 ext 4160 joerg.kotzerke@uniklinikum-dresden.de | |||||
Principal Investigator: Joerg Kotzerke, MD |
Dresden University of Technology |
Pfizer |
Principal Investigator: | Heinz Reichmann, MD | Technical University of Dresden |
Homepage of principle location 
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Study ID Numbers: | 91052003 |
First Received: | September 7, 2005 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00153972 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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