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

This study has been completed.
Information provided by:
Molecular NeuroImaging Identifier:
First received: September 12, 2005
Last updated: January 17, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Parkinson's Disease Drug: carbidopa/l-dopa Drug: carbidopa/l-dopa/entacapone Drug: Stalevo Procedure: [123I]-IBZM imaging Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)

Resource links provided by NLM:

Further study details as provided by Molecular NeuroImaging:

Primary Outcome Measures:
  • The primary outcome will be the reduction from baseline in IBZM striatal uptake during a 6-8 hour assessment period after treatment. [ Time Frame: 6-8hrs ]

Secondary Outcome Measures:
  • Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis. [ Time Frame: 6-8hrs ]

Enrollment: 3
Study Start Date: March 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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-dopa/entacapone to produce displacement of striatal radioactivity for assessment of intrasynaptic dopamine. We will assess the feasibility of this paradigm for detecting l-dopa effects on the SPECT signal in subjects with PD with disease duration of greater than 4yrs and with a stable response to L-dopa. Each subject will undergo three [123I]-IBZM studies separated by 1-2 weeks. Subjects will be off medication for at least 12 h prior to study For each of the three scan days patients will receive a constant intravenous infusion of [123I]-IBZM over 4-5 hours to establish an equilibrium binding condition of the radiotracer at striatal D2/D3 receptors. Three baseline SPECT acquisitions will be obtained prior to medication dosing to establish a stable baseline. At approximately 5 h after the initiation of the infusion subjects will receive a single oral dose of either carbidopa/levodopa (37.5mg/150mg or 50mg/250mg), or carbidopa/levodopa/entacapone (either 37.5mg/150mg/200mg- STALEVO or 50/250mg/200mg).

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00200447

Sponsors and Collaborators
Molecular NeuroImaging
Principal Investigator: John P Seibyl, MD Molecular NeuroImaging
  More Information

Responsible Party: John Seibyl M.D., molecular NeuroImaging Identifier: NCT00200447     History of Changes
Other Study ID Numbers: MNI 0011
Study First Received: September 12, 2005
Last Updated: January 17, 2008

Keywords provided by Molecular NeuroImaging:
brain imaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors processed this record on September 20, 2017