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

Phase 2
Completed
Conditions
Parkinson's Disease
Parkinsonian Syndrome
Registration Number
NCT00132626
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary Outcome Measures
NameTimeMethod
Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred
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