Clinical trial NCT00129181: Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Parkinsonian Syndrome
Keywords: parkinson
brain imaging
diagnosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: Pfizer
name: GE Healthcare
First posted: 2005-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease
timeFrame: 1 year
Secondary outcomes:
measure: To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease
timeFrame: 1 year
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Neurology, Innsbruck Medical University
city: Vienna
country: Austria
facility: Neurological Department, Wilhelminenspital
city: Leipzig
country: Germany
facility: Dept. of Neurology, University of Leipzig
city: Marburg
country: Germany
facility: Dept. of Neurology Marburg, Phillips-Univ.
city: München
country: Germany
facility: Ambulanz für Bewegungsstörungen, Neurologische Poliklinik
city: Catania
country: Italy
facility: University of Catania-Department of Neurosciences
city: Milan
country: Italy
facility: Parkinson Institute Milan
city: Naples
country: Italy
facility: Department of Neurological Sciences-University of Napoli
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: The Institute for Neurodegenerative Disorders
name: Kenneth L Marek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Institute for Neurodegenerative Disorders
name: John P Seibyl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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