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

This study has been completed.
Sponsor:
Collaborators:
Molecular NeuroImaging
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00132626
First received: August 18, 2005
Last updated: February 20, 2007
Last verified: February 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

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

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

Estimated Enrollment: 500
Study Start Date: September 1992
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132626

Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Investigators
Principal Investigator: Kenneth Marek, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00132626     History of Changes
Other Study ID Numbers: Dopamine Transporter Imaging
Study First Received: August 18, 2005
Last Updated: February 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
diagnosis

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

ClinicalTrials.gov processed this record on July 29, 2014