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A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease

This study is currently recruiting participants.
Verified May 2013 by Institute for Neurodegenerative Disorders
Sponsor:
Collaborators:
Indiana University
Albany Medical College
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00117819
First received: June 30, 2005
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  Purpose

This study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. Participants will have brain imaging to assess dopamine transporter density. The imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.


Condition Intervention Phase
Parkinsonian Syndrome
 Drug: [123I]ß CIT and SPECT imaging
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • CIT uptake is the Specific: Nondisplaceable striatal uptake ratio [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CIT uptake measures from at-risk individuals will be compared with healthy subjects. [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: March 2001
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [123I]ß CIT and SPECT imaging
To assess [123I]ß-CIT and SPECT imaging
 Drug: [123I]ß CIT and SPECT imaging
To assess [123I]ß CIT and SPECT imaging
Other Names:
  • [123I]ß CIT
  • SPECT imaging

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.

On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

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

Participants may be contacted to repeat these procedures every 12 to 18 months.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 22 years or older
  • A clinical diagnosis of Parkinson's disease (PD), positive family history of PD and/or potential exposure to environmental toxins
  • Normal screening laboratory studies

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117819

Contacts
Contact: Susan Mendick, MPH 203-401-4300 smendick@indd.org

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Contact: Barbara Fussell, RN     203-401-4300     bfussell@indd.org    
Contact: Susan Mendick, MPH     203-401-4300     smendick@indd.org    
Principal Investigator: Kenneth L. Marek, MD            
Sub-Investigator: Danna Jennings, MD            
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Indiana University
Albany Medical College
Investigators
Principal Investigator: Kenneth L. Marek, MD President and Senior Scientist
  More Information

Publications:
Marek, K., J. Seibyl, et al. (1999). "[123I] ß-CIT/SPECT: Assessment of determinants of variability in progression of Parkinson's disease." Neurology 52: A91-92.
Marek, K., J. Seibyl, et al. (1996). "Dopamine transporter and receptor imaging in Parkinsonism. (Presented at the 4th International Congress of Movement Disorders, Vienna, Austria; June, 1996.)." Mov Dis 6.

Responsible Party: Kenneth Marek, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00117819     History of Changes
Other Study ID Numbers: At-Risk
Study First Received: June 30, 2005
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
family history
diagnosis

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

ClinicalTrials.gov processed this record on June 13, 2013