NCT00397696

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

Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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 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. The primary imaging outcome measure will be VT', the equilibrium distribution volume in brain regions is determined from an MRI-directed region-of-interest (ROI) analysis. The baseline imaging VT' will be compared to the follow-up imaging study to the reliability of the nicotinic \[123I\] 5-IA imaging.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	[123I] 5-IA	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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2006-11-09
• Last updated: 2014-05-07

Locations

1 site across 1 country: United States