Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00153972

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

Duration (Months)

19.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Cabergoline Drug: Levodopa	Phase 4

Detailed Description

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology at the Technical University of Dresden	Dresden	Saxony	Germany	01307
2	Department of Nuclear Medicine at the Technical University of Dresden	Dresden	Saxony	Germany	01307