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

Further Study Details: 

Primary Outcomes: 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.
Secondary Outcomes: Changes of clinical outcome measured with parkinsonian rating scales (UPDRS, PDQ-39, ESS, olfactory function)
Expected Total Enrollment:  40

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 a double-blind, randomized monocenter 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:

• Current or past dopaminergic treatment
• Atypical parkinsonian syndromes
• Treatment with neuroleptics (present and past)

Methods:

• Fluoro-dopa-PET for measuring the dopamine turnover rate
• clinical investigations including parkinsonian rating scales (e.g. UPDRS, PDQ-39, etc.)
• olfactorical tests

Study medication:

• Cabergoline (1 to 3 mg once per day)
• Levodopa/carbidopa (50 until 300 mg levodopa per day in one to three dosages)

Ages Eligible for Study:  40 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Early (de novo) Parkinson''''s disease (Hoen & Yahr I and II), according to the UK brain bank criteria

Exclusion Criteria:

• Current or past dopaminergic treatment
• Atypical parkinsonian syndromes
• Treatment with neuroleptics (present and past)
• Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00153972

Heinz Reichmann, MD      ++49-351-458-0  Ext. 3565    heinz.reichmann@uniklinikum-dresden.de
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, Dresden,  Saxony,  01307,  Germany; Recruiting
      Department of Nuclear Medicine at the Technical University of Dresden, Dresden,  Saxony,  01307,  Germany; Recruiting

Study chairs or principal investigators

Heinz Reichmann, MD,  Principal Investigator,  Technical University of Dresden   

Study ID Numbers:  91052003
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153972
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13