NCT06151808

Analysis of XTR006 PET Imaging in Non-cognitively Impaired Subjects, MCI Due toAD, and Mild to Moderate AD Subjects

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is an investigator-initiated clinical (IIT)study.The main purpose of this study was to evaluate the diagnostic efficacy of XTR006 PET qualitative reading and quantitative analysis in detecting mild cognitive impairment（MCI）due 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 Alzheimer's 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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	XTR006	All participants will receive a single intravenous dose of 8.0-10.0mCi of XTR006 followed by PET scan

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-11-28
• Completion: 2024-01-10
• First posted: 2023-11-30
• Last updated: 2024-05-03

Locations

1 site across 1 country: China