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

Study Overview
=================
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.

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

Conditions
-----------------
Parkinsonian Syndrome

Intervention / Treatment
-----------------
* Drug: [123I]ß CIT and SPECT imaging


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [123I]ß CIT and SPECT imaging<br>To assess [123I]ß-CIT and SPECT imaging | Drug: [123I]ß CIT and SPECT imaging<br>* To assess [123I]ß CIT and SPECT imaging<br>* Other names: SPECT imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIT uptake is the Specific: Nondisplaceable striatal uptake ratio |  | 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIT uptake measures from at-risk individuals will be compared with healthy subjects. |  | 2 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parkinson, family history, diagnosis