Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00886951
Status:
TERMINATED
Last Update Posted:
2019-04-03
First Post:
2009-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Photon Emission Computed Tomography (SPECT) Imaging Study to Develop a Biomarker for Alzheimer's Disease
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Study Overview
Official Title:
Evaluation of [123I] MNI-388 and 123-I MNI-390 and SPECT as Markers of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There seemed to be no uptake of the ligand in the areas of the brain expected for subjects with amyloid.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives of this proposal are as follows:
* To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
* To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging agent
* To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
* To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging agent
Detailed Description:
The adaptation of imaging agents like 123-I MNI-388 and 123-I MNI-390 as biomarkers of β-amyloid deposition in AD patients for assessing disease requires human validation studies. The purpose of this study is to develop and characterize 123-I MNI-388 and 123-I MNI-390 as objective biomarkers in AD. The significance of this work lies in applying state-of-art quantitative neuroimaging tools to develop a relevant biomarker in living AD patients. In this context we propose to investigate the feasibility of applying this technique as an imaging biomarker of disease in AD patients.
Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be given a bolus injection of 123-I MNI-388 and MNI 390 in an antecubital vein. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-388 and MNI 390 in plasma (both protein bound and free) over a period of up to 8 hours. The quantitative and visual imaging analyses will be performed by an image-processing specialist who will remain blinded to any clinical information.including diagnosis. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-388 and MNI-390. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be given a bolus injection of 123-I MNI-388 and MNI 390 in an antecubital vein. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-388 and MNI 390 in plasma (both protein bound and free) over a period of up to 8 hours. The quantitative and visual imaging analyses will be performed by an image-processing specialist who will remain blinded to any clinical information.including diagnosis. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-388 and MNI-390. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
Study Oversight
Has Oversight DMC:
False
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?: