Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153972
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2005-09-07
Brief Title:
Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinsons Disease
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 Parkinsons 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
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 Parkinsons 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
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 Parkinsons 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 Parkinsons 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 Parkinsons 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 eg UPDRS PDQ-39 etc
olfactory tests
Study medication
Cabergoline 1 to 3 mg once per day
Levodopacarbidopa 50 until 300 mg levodopa per day in one to three dosages
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinsons 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 Parkinsons 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 eg UPDRS PDQ-39 etc
olfactory tests
Study medication
Cabergoline 1 to 3 mg once per day
Levodopacarbidopa 50 until 300 mg levodopa per day in one to three dosages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None