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

Overview

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.

Full Title of Study: “Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)

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.

Interventions

  • Drug: [123I]ß-CIT and SPECT imaging

Clinical Trial Outcome Measures

Primary Measures

  • CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness

Secondary Measures

  • Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute for Neurodegenerative Disorders
  • Collaborator
    • Molecular NeuroImaging
  • Overall Official(s)
    • Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders

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