Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397696
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2006-11-07
Brief Title:
Evaluation of 5-123I-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
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
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None