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Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

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ClinicalTrials.gov Identifier: NCT00132626
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : February 21, 2007
Sponsor:
Collaborators:
Molecular NeuroImaging
National Institutes of Health (NIH)
Information provided by:
Institute for Neurodegenerative Disorders

Brief Summary:
This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Parkinsonian Syndrome Procedure: [123I]ß-CIT and SPECT imaging Phase 2

Detailed Description:

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.


Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
Study Start Date : September 1992
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness

Secondary Outcome Measures :
  1. Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 21 years of age
  • Normal screening laboratory studies
  • At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment

Exclusion Criteria:

  • Pregnancy
  • Significant medical disease including abnormalities found on screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132626


Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kenneth Marek, MD Institute for Neurodegenerative Disorders

ClinicalTrials.gov Identifier: NCT00132626     History of Changes
Other Study ID Numbers: Dopamine Transporter Imaging
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
diagnosis

Additional relevant MeSH terms:
Syndrome
Parkinson Disease
Disease
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases