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Completed

NCT Number: NCT00129181

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Parkinsonian Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Innsbruck Medical University, Innsbruck, Austria

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About this study

This is a multi-center, open-label study of short-term treatment with levodopa or cabergoline on striatal DATscan uptake in early Parkinson's disease. Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is aged 40 years or older.
  • Written informed consent is obtained.
  • Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
  • Hoehn and Yahr stages for subjects are I-II.

Exclusion criteria

  • The subject has atypical or drug-induced Parkinson's disease.
  • The subject has dementia.
  • The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  • The subject is pregnant.

Treatment and study plan

cabergoline

Drug

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Carbidopa/levodopa

Drug

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

DATscan and SPECT imaging

Procedure

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Primary outcomes

  1. To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease

    Time frame: 1 year

Secondary outcomes

  1. To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease

    Time frame: 1 year

  2. To further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Institute for Neurodegenerative Disorders

Other

Collaborators

  • GE Healthcare
  • Pfizer

Registry information

Official study title

A Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's Disease

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Aug 11, 2005
Registry last updated
Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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