Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480701
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2007-05-30
Brief Title:
Evaluation of 123-I Iodobenzovesamicol IBVM and SPECT Imaging of Healthy Subjects and Patients With Alzheimer Disease
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
Evaluation of 123-I Iodobenzovesamicol IBVM and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer Disease
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:
IBVM001
Brief Summary:
The underlying goal of this study is to assess 123-I IBVM SPECT imaging as a tool to assess cholinergic transporter binding in the brain of AD and PD research participants and age- and gender-matched healthy subjects
Detailed Description:
Approximately 25 patients with mild to moderate Alzheimers disease AD and 25 patients Parkinsons disease and 20 healthy controls will be recruited to participate in this study
AD patients will be eligible to participate if they have a diagnosis of AD based on NINCDS-ADRDA criteria
PD patients will be eligible to participate if they have a clinical diagnosis of Parkinsons disease
Healthy controls will be evaluated to ensure that there is no evidence of neurodegenerative changes including cognitive decline
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing a physical and neurological evaluation and cognitive assessment
Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours
Subjects may be asked to undergo a second imaging visit two-weeks to six months following the initial imaging visit to assess the reproducibility of the imaging outcome andor the progressive change from baseline in 123-I IBVM binding
The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical diagnosis The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to cerebellar ratio
AD patients will be eligible to participate if they have a diagnosis of AD based on NINCDS-ADRDA criteria
PD patients will be eligible to participate if they have a clinical diagnosis of Parkinsons disease
Healthy controls will be evaluated to ensure that there is no evidence of neurodegenerative changes including cognitive decline
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing a physical and neurological evaluation and cognitive assessment
Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours
Subjects may be asked to undergo a second imaging visit two-weeks to six months following the initial imaging visit to assess the reproducibility of the imaging outcome andor the progressive change from baseline in 123-I IBVM binding
The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical diagnosis The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to cerebellar ratio
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