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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.
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Purpose
| 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
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
Accepts Healthy Volunteers
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
Location and Contact Information
Connecticut
Institute for Neurodegenerative Disorders, New Haven, Connecticut, 06510, United States; Recruiting
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
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.
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
Resources
- Careers in Sports Medicine and Exercise Science (American College of Sports Medicine)
- Sports Medicine (National Women's Health Information Center)
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