Clinical Trial: A Study of Brain Imaging with Nuclear Medicine Technology in Individuals with and At Risk for Parkinson''s Disease

This study is currently recruiting patients.

Sponsors and Collaborators: Institute for Neurodegenerative Disorders
Indiana University
Albany Medical Center
Information provided by: Institute for Neurodegenerative Disorders

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
 Procedure: [123I]ß CIT and SPECT imaging
Phase II

MedlinePlus related topics:  Brain Diseases;   Movement Disorders

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Dynamic SPECT Imaging with [123I] B-CIT in Individuals with Parkinsonian Syndrome (PS) and in Individuals At Risk for Parkinsonian Syndrome

Further Study Details: 
Primary Outcomes: CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
Secondary Outcomes: CIT uptake measures from at-risk individuals will be compared with healthy subjects.
Expected Total Enrollment:  350

Study start: March 2001

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 above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00117819

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

Connecticut
      Institute for Neurodegenerative Disorders, New Haven,  Connecticut,  06510,  United States; Recruiting
Barbara Fussell, RN  203-401-4300    bfussell@indd.org 
Susan Mendick, MPH  203-401-4300    smendick@indd.org 
Kenneth L. Marek, MD,  Principal Investigator
Danna Jennings, MD,  Sub-Investigator
Tabamo Rowena, MD,  Sub-Investigator

Study chairs or principal investigators

Kenneth L. Marek, MD,  Principal Investigator,  President and Senior Scientist   

More Information

Publications

Koller WC, Langston JW, Hubble JP, Irwin I, Zack M, Golbe L, Forno L, Ellenberg J, Kurland L, Ruttenber AJ, et al. Does a long preclinical period occur in Parkinson''''s disease? Neurology. 1991 May;41(5 Suppl 2):8-13. Review. No abstract available.

Morrish PK, Sawle GV, Brooks DJ. An [18F]dopa-PET and clinical study of the rate of progression in Parkinson''''s disease. Brain. 1996 Apr;119 ( Pt 2):585-91.

Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson''''s disease. Ann Neurol. 1995 Oct;38(4):589-98.

Study ID Numbers:  At-Risk
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 7, 2005
ClinicalTrials.gov Identifier:  NCT00117819
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26



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