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

NCT00153972

Last updated date
Study Location
Department of Neurology at the Technical University of Dresden
Dresden, Saxony, 01307, Germany
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Early (de novo) Parkinson's disease (Hoen & Yahr I and II), according to the UK brain bank criteria

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current or past dopaminergic treatment


- Atypical parkinsonian syndromes


- Treatment with neuroleptics (present and past)


- Pregnancy

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease
Official Title  ICMJE Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease
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.

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.

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Cabergoline
  • Drug: Levodopa
Study Arms  ICMJE
  • Active Comparator: Levodopa
    Levodopa 300 mg per day orally.
    Interventions:
    • Drug: Cabergoline
    • Drug: Levodopa
  • Active Comparator: Cabergoline
    Cabergoline 3 mg per day orally.
    Interventions:
    • Drug: Cabergoline
    • Drug: Levodopa
Publications * Oehme L, Perick M, Beuthien-Baumann B, Wolz M, Storch A, Löhle M, Herting B, Langner J, van den Hoff J, Reichmann H, Kotzerke J. Comparison of dopamine turnover, dopamine influx constant and activity ratio of striatum and occipital brain with ¹?F-dopa brain PET in normal controls and patients with Parkinson's disease. Eur J Nucl Med Mol Imaging. 2011 Aug;38(8):1550-9. doi: 10.1007/s00259-011-1819-8. Epub 2011 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2012)
39
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
40
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00153972
Other Study ID Numbers  ICMJE 91052003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexander Storch, Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Heinz Reichmann, MDTechnical University of Dresden
PRS Account Technische Universität Dresden
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP