Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease
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Purpose
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.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Cabergoline Drug: Levodopa |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease |
- 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.
- Changes of clinical outcome measured with parkinsonian rating scales (UPDRS, PDQ-39, ESS, olfactory function)
| Enrollment: | 39 |
| Study Start Date: | February 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Levodopa
Levodopa 300 mg per day orally.
|
Drug: Cabergoline Drug: Levodopa |
|
Active Comparator: Cabergoline
Cabergoline 3 mg per day orally.
|
Drug: Cabergoline Drug: Levodopa |
Detailed 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 specific aim of the study was to estimate normal ranges and test-retest measures for various parameters characterising dopamine metabolism from a prolonged 18F-dopa positron emission tomography (PET) measurement using a reference tissue model and compare their value for the detection of early PD.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications. The specific aim is to evaluate the effects of levodopa and the dopamine D2 agonist cabergoline on striatal dopamine turnover estimated as the inverse of the effective dopamine distribution volume ratio (EDVR) measured by 18F-dopa PET in de-novo PD.
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)
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| Department of Neurology at the Technical University of Dresden | |
| Dresden, Saxony, Germany, 01307 | |
| Department of Nuclear Medicine at the Technical University of Dresden | |
| Dresden, Saxony, Germany, 01307 | |
| Principal Investigator: | Heinz Reichmann, MD | Technical University of Dresden |
More Information
Additional Information:
Publications:
| Responsible Party: | Alexander Storch, Professor, Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00153972 History of Changes |
| Other Study ID Numbers: | 91052003 |
| Study First Received: | September 7, 2005 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Dresden University of Technology:
|
Parkinson's disease Fluoro-Dopa-PET Dopamine agonists |
Cabergoline Surrogate marker Dopamine turnover |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Dopamine Dopamine Agents Levodopa Cabergoline Cardiotonic Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Antineoplastic Agents Dopamine Agonists |
ClinicalTrials.gov processed this record on May 21, 2013