Status:
COMPLETED
An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)
Lead Sponsor:
Molecular NeuroImaging
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses \[123I\]-IBZM and dynamic SPECT imaging to determine the amou...
Detailed Description
This is a pilot evaluation of dopaminergic function in PD using a bolus plus constant infusion protocol with \[123I\]-IBZM and SPECT to evaluate the potential for carbidopa/l-dopa alone or carbidopa/l...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- The patient is aged 30 years or older.
- Written informed consent is obtained.
- Patients have a diagnosis of idiopathic Parkinson's disease.
- Hoehn and Yahr stages for patients are I-III.
- Patients have a diagnosis\> 4 yrs prior to screening
- Patients are treated with carbidopa/levodopa with \> 300 mg levodopa.
- Main exclusion criteria:
- The patient has atypical or drug-induced Parkinson's disease.
- The patient has dementia (MMSE 24).
- The patient has a clinically significant clinical laboratory values, and/or medical or psychiatric illness.
- The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The patient has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The patient has been treated with a dopamine agonist within the past 30 days.
- Concomitant treatment with Monoamine Oxidase (MAO)-inhibitors (except selegiline \<10 mg/day) within 30 days prior to the screening visit
- Patient has a history of iodine allergy
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00200447
Start Date
March 1 2004
End Date
September 1 2004
Last Update
January 21 2008
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