Parkinson Disease, Parkinsonian Syndrome
Conditions
Keywords
parkinson, brain imaging, diagnosis
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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
Interventions
DRUGcabergoline
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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
PROCEDUREDATscan and SPECT imaging
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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
Sponsors
Pfizer
GE Healthcare
Institute for Neurodegenerative Disorders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease | 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 | 2 years |
Countries
Austria, Germany, Italy, Spain
Outcome results
None listed