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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00117819
Other study ID # At-Risk
Secondary ID
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


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
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