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

Institute for Neurodegenerative Disorders30 enrolled

Overview

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.

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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease Parkinsonian Syndrome

Interventions

cabergolineDRUG

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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).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

DATscan and SPECT imaging

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (9)

Department of Neurology, Innsbruck Medical University

Innsbruck, Austria

Neurological Department, Wilhelminenspital

Vienna, Austria

Dept. of Neurology, University of Leipzig

Leipzig, Germany

Dept. of Neurology Marburg, Phillips-Univ.

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

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

Data from ClinicalTrials.gov

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