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

This study has been completed.
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: April 9, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 232
Study Start Date: March 2001
Study Completion Date: January 2013
Primary Completion Date: January 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
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: NCT00117819

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
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:
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: April 9, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014