Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The underlying goal of this study is to assess [123I] 5-IA and SPECT imaging as a tool to detect nicotinic receptor activity in the brain of PD patients. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with a diagnosis of PD without cognitive changes will be recruited to participate in this study. Patients will be eligible to participate if they have a diagnosis of PD of more than 2 years duration and have no significant cognitive changes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders
• Collaborator: United States Department of Defense

Criteria

Inclusion Criteria:

• The presence of idiopathic Parkinson disease

• A clear clinical response to dopaminergic therapy treatment

• Hoehn and Yahr Stages < 3;

• 2-7 year Duration from time of diagnosis.

• Mini-mental status exam score of >24,

• For females, non-child bearing potential or negative urine pregnancy test on day of [123I] 5-IA injection.

Exclusion Criteria:

• Secondary Parkinsonism;

• Nicotine dependence or use within the previous 12 months prior to enrollment;

• Treatment with Aricept (donepezil), Exelon (rivastigmine), Cognex (tacrine) within the past 30 days; treatment with medications that bind to the nicotinic receptor.

• Clinically significant clinical laboratory value and/or medical or psychiatric illness;

• Mini-mental status exam score of ≤24.

• The subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;

• The subject has received an investigational drug within 30 days of the screening visit;

• Pregnancy