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

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

ChemIDplus related topics:

Dopamine Dopamine hydrochloride Levodopa 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
Estimated Study Completion Date:	August 2007

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

Contacts


Contact: Heinz Reichmann, MD	++49-351-458-0 ext 3565	heinz.reichmann@uniklinikum-dresden.de

Contact: Alexander Storch, MD	++49-351-458-0 ext 2532	alexander.storch@neuro.med.tu-dresden.de

Locations


Germany, Saxony
	Department of Neurology at the Technical University of Dresden	Recruiting
	Dresden, Saxony, Germany, 01307
	Contact: Alexander Storch, MD ++49-351-458-0 ext 2532 alexander.storch@neuro.med.tu-dresden.de
	Contact: Martin Wolz, MD ++49-351-458-0 ext 3886 martin.wolz@neuro.med.tu-dresden.de
	Sub-Investigator: Martin Wolz, MD
	Sub-Investigator: Alexander Storch, MD
	Principal Investigator: Heinz Reichmann, MD
	Department of Nuclear Medicine at the Technical University of Dresden	Recruiting
	Dresden, Saxony, Germany, 01307
	Contact: Joerg Kotzerke, MD ++ 49-351-458-0 ext 4160 joerg.kotzerke@uniklinikum-dresden.de
	Principal Investigator: Joerg Kotzerke, MD

Sponsors and Collaborators

Dresden University of Technology

Pfizer

Investigators


Principal Investigator:	Heinz Reichmann, MD	Technical University of Dresden

More Information

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

Study ID Numbers:	91052003
First Received:	September 7, 2005
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00153972
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:

Levodopa

Ganglion Cysts

Basal Ganglia Diseases

Disease Progression

Central Nervous System Diseases

Brain Diseases

Neurodegenerative Diseases

Dopamine

Parkinson Disease

Movement Disorders

Dihydroxyphenylalanine

Parkinsonian Disorders

Cabergoline

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Antineoplastic Agents

Cardiotonic Agents

Sympathomimetics

Nervous System Diseases

Physiological Effects of Drugs

Antiparkinson Agents

Cardiovascular Agents

Dopamine Agonists

Protective Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008

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