Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456417
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2007-04-03
Brief Title:
Evaluation of 123I MNI-187 and SPECT in Patients With Alzheimers Disease in Comparison to Healthy Subjects
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
Evaluation of 123I MNI-187 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
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 123-I MNI-187 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects
Detailed Description:
Approximately 14 patients with Alzheimers disease AD and 12 healthy controls will be recruited to participate in this study Healthy controls will be examined 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 baseline physical and neurological evaluation and baseline cognitive evaluations
Subjects will be asked to undergo a bolus injection of 123-I MNI-187 Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187 in plasma both protein bound and free over a period of up to 6 hours
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition
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-187 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
For those subjects undergoing repeat imaging visits the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure
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
Subjects will be asked to undergo a bolus injection of 123-I MNI-187 Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187 in plasma both protein bound and free over a period of up to 6 hours
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition
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-187 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
For those subjects undergoing repeat imaging visits the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure
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