An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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 amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular NeuroImaging
• Treatments: Carbidopa; Dihydroxyphenylalanine; Entacapone; Levodopa

Criteria

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