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

Sponsors and Collaborators:	Institute for Neurodegenerative Disorders Indiana University Albany Medical College
Information provided by:	Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:	NCT00117819

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

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 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 Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: [123I]ß CIT and SPECT imaging 1473 WIRB: Dynamic SPECT Imaging with [123I]ß-CIT in Healthy Controls and Individuals at Risk for Parkinsonism due to Family History of Parkinsonism or Exposure to an Environmental Toxin Potentially Associated with Parkinsonism

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

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:

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.

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.

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.

Responsible Party:	Institute for Neurodegenerative Disorders ( Danna L. Jennings, MD )
Study ID Numbers:	At-Risk
Study First Received:	June 30, 2005
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00117819 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:

parkinson
family history
diagnosis

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Brain Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Movement Disorders
Syndrome
Nervous System Diseases

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009