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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00117819
Enrollment
232
Registered
2005-07-08
Start date
2001-03-31
Completion date
2013-01-31
Last updated
2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsonian Syndrome

Keywords

parkinson, family history, diagnosis

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.

Interventions

DRUG[123I]ß CIT and SPECT imaging

To assess \[123I\]ß CIT and SPECT imaging

Sponsors

Indiana University
CollaboratorOTHER
Albany Medical College
CollaboratorOTHER
Institute for Neurodegenerative Disorders
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio2 yrs

Secondary

MeasureTime frame
CIT uptake measures from at-risk individuals will be compared with healthy subjects.2 yrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026