At a glance
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Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects
In Brief
A Phase 2 clinical trial evaluating [123I] 5-IA for Parkinson Disease. Completed, enrolled 9 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 evaluations using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of \[123I\] 5-IA followed by SPECT imaging as described below. A second \[123I\] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial \[123I\] 5IA imaging session.