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

Parkinsonian Syndrome Clinical Trial

Official title:

Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117819
• Other study ID #: At-Risk
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: April 9, 2014
• Start date: March 2001
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinsonian Syndrome

Intervention

Drug:
• [123I]ß CIT and SPECT imaging
To assess [123I]ß CIT and SPECT imaging

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders	Albany Medical College, Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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.

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.

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. — View Citation

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. Erratum in: Ann Neurol. 1996 Mar;39(3):417. van Dyck, C [added]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIT uptake is the Specific: Nondisplaceable striatal uptake ratio		2 yrs	Yes
Secondary	CIT uptake measures from at-risk individuals will be compared with healthy subjects.		2 yrs	Yes