Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease - Full Text View

Sponsors and Collaborators:	Dresden University of Technology Pfizer
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00153972

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.

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

Drug Information available for: Dopamine Levodopa Dopamine hydrochloride Cabergoline Cabergoline diphosphate

U.S. FDA Resources

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

Further study details as provided by Dresden University of Technology:

Primary Outcome 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 Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	February 2005
Study Completion Date:	January 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153972

Locations

Germany, Saxony
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

Sponsors and Collaborators

Dresden University of Technology

Pfizer

Investigators

Principal Investigator:

Heinz Reichmann, MD

Technical University of Dresden

More Information

Additional Information:

Homepage of principle location This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	91052003
Study First Received:	September 7, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00153972 History of Changes
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

Study placed in the following topic categories:

Neurotransmitter Agents
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Disease Progression
Central Nervous System Diseases
Cardiovascular Agents
Brain Diseases
Neurodegenerative Diseases

Dopamine Agonists
Dopamine
Parkinson Disease
Movement Disorders
Dihydroxyphenylalanine
Dopamine Agents
Peripheral Nervous System Agents
Parkinsonian Disorders
Cabergoline

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Antineoplastic Agents
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Neurodegenerative Diseases
Brain Diseases
Dopamine
Movement Disorders
Therapeutic Uses

Sympathomimetics
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Parkinson Disease
Autonomic Agents
Dopamine Agents
Parkinsonian Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Cabergoline

ClinicalTrials.gov processed this record on May 07, 2009