Clinical trial NCT00117819: A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
Official title: Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinsonian Syndrome
Keywords: parkinson
family history
diagnosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Albany Medical College
First posted: 2005-07-08
Enrollment: 232
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
timeFrame: 2 yrs
Secondary outcomes:
measure: CIT uptake measures from at-risk individuals will be compared with healthy subjects.
timeFrame: 2 yrs
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: President and Senior Scientist
name: Kenneth L. Marek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: 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.
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. doi: 10.1002/ana.410380407.