Dopamine Turnover Rate as Surrogate Parameter for Diagnosis 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
- Study Primary Completion Date: September 2008
Detailed Clinical Trial Description
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
Outcome Measures for this Clinical Trial
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)
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Dresden University of Technology Other
Overall Clinical Trial Officials and Contacts
Heinz Reichmann, MD Principal Investigator Technical University of Dresden
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00153972
