A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
NCT ID: NCT00117819
Last Updated: 2014-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
232 participants
INTERVENTIONAL
2001-03-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[123I]ß CIT and SPECT imaging
To assess \[123I\]ß-CIT and SPECT imaging
[123I]ß CIT and SPECT imaging
To assess \[123I\]ß CIT and SPECT imaging
Interventions
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[123I]ß CIT and SPECT imaging
To assess \[123I\]ß CIT and SPECT imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Psychiatric disease other than history of depression
* Significant medical disease including abnormalities on screening
22 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Albany Medical College
OTHER
Institute for Neurodegenerative Disorders
OTHER
Responsible Party
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Kenneth Marek, MD
Principal Investigator
Principal Investigators
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Kenneth L. Marek, MD
Role: PRINCIPAL_INVESTIGATOR
President and Senior Scientist
Locations
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Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Countries
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References
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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. 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. doi: 10.1093/brain/119.2.585.
Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, 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. doi: 10.1002/ana.410380407.
Other Identifiers
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At-Risk
Identifier Type: -
Identifier Source: org_study_id
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