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

Phase 2

Completed

• Conditions: Parkinsonian Syndrome
• Interventions: Drug: [123I]ß CIT and SPECT imaging

• Registration Number: NCT00117819
• Lead Sponsor: Institute for Neurodegenerative Disorders

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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-04
• Disposition First Submitted: 2014-04-09
• Disposition First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Disposition First Posted: 2014-05-02
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[123I]ß CIT and SPECT imaging	[123I]ß CIT and SPECT imaging	To assess \[123I\]ß-CIT and SPECT imaging

Primary Outcome Measures

Name	Time	Method
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio	2 yrs

Secondary Outcome Measures

Name	Time	Method
CIT uptake measures from at-risk individuals will be compared with healthy subjects.	2 yrs

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States