Official Title: “Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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: - 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.) - olfactory 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)

Intervention(s) in this Clinical Trial

• Drug: Cabergoline
• Drug: Levodopa

Primary Measures

• 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 Measures

• Changes of clinical outcome measured with parkinsonian rating scales (UPDRS, PDQ-39, ESS, olfactory function)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Heinz Reichmann, MD Principal Investigator Technical University of Dresden  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153972

Study ID Number: 91052003

ClinicalTrials.gov Identifier: NCT00153972

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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