Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).
Conditions
Interventions
Trade Name: Sinemet
Product Name: Sinemet
Pharmaceutical Form: Tablet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaseril
Product Name: Cabaseril
Pharmaceutical Form: Tablet
INN or Proposed
Sponsors
Institute for Neurodegenerative Disorders
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) The subject is aged 40 years or older. (b) Written informed consent is obtained. (c) Subjects have a diagnosis of idiopathic Parkinson’s disease. (d) Hoehn and Yahr stages for subjects are I-II. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (a) The subject has atypical or drug-induced Parkinson’s disease. (b) The subject has dementia. (c) The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness. (d) The subject is pregnant. (e) The subject has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2}within the past 2 years. (f) The subject has received an investigational drug within 30 days before the screening visit. (g) The subject has been treated with any anti-Parkinson drug including levodopa, dopamine agonists (including pramipexole, ropinirole, cabergoline, pergolide), amantadine, selegeline, rasagiline for greater than a total of 14 days or at any time within 60 days of the baseline visit. (h) The subject has used any prescription or clinically significant over-the-counter (OTC) drugs disallowed by the protocol (anticholinergic drugs, dopamine antagonists, or antihistamines as identified in section 6) within 14 (60 days for antiparkinson’s agents) days before the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A. To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson’s disease. B. To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson’s disease. ;Secondary Objective: C. This study will also serve 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. ;Primary end point(s): The primary outcome measure will be striatal dopamine transporter density. This is a region of interest (ROI) based analysis (calculated as [total striatal uptake/nondisplaceable uptake]-1) of the striatum. Also putamen and caudate uptake and UPDRS scores | — |
Countries
Austria, Spain, United Kingdom
Outcome results
None listed