Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151808
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2023-08-25
Brief Title:
Analysis of XTR006 PET Imaging in Non-cognitively Impaired Subjects MCI Due toAD and Mild to Moderate AD Subjects
Sponsor:
Sinotau Pharmaceutical Group
Organization:
Sinotau Pharmaceutical Group
Study Overview
Official Title:
An Open-label Non-randomized Single-center Study Evaluating the Imaging Characteristics of XTR006 Injection in Non-cognitively Impaired Subjects MCI Due to Alzheimer Disease AD and Mild to Moderate AD Subjects
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This is an investigator-initiated clinical IITstudyThe main purpose of this study was to evaluate the diagnostic efficacy of XTR006 PET qualitative reading and quantitative analysis in detecting mild cognitive impairmentMCIdue to AD and mild to moderate AD based on clinical diagnosis and to establish XTR006 PET imaging parameters and qualitative reading and quantitative analysis methods
Detailed Description:
XTR006 is a 18F-labeled PET tracer for the quantification of neurofibrillary tangle NFT deposition in the brain Brain NFT deposition is a pathologic finding in Alzheimers Disease AD with brain NFT density shown to correlate with the severity of cognitive impairment in AD 90 Chinese subjects 30 subjects with non-cognitive impairment 30 subjects with MCI due to AD and 30 subjects with mild to moderate AD who meet all of the inclusion and none of the exclusion criteriawill be enrolled in this IIT study Subjects will receive 8-10mCi of XTR006 via IV injection qualitative reading and quantitative analysis methods will be investigated Safety and tolerability will be observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None