Status:
COMPLETED
Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborating Sponsors:
United States Department of Defense
Conditions:
Parkinson Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 th...
Detailed Description
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive eva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00397696
Start Date
November 1 2006
End Date
January 1 2012
Last Update
May 7 2014
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510