A Phase 3, Multicenter Study to Evaluate the Efficacy and Safety of PET Visual Assessment Using XTR006 Injection for Detection of Brain Neurofibrillary Tangles (NFTs) in Elderly Subjects

This is a multicenter, single-blind, non-randomized phase III study. The study aims to evaluate the effectiveness of XTR006 PET imaging visual reads for detecting NFTs in subjects. The trial procedures for all subjects include a screening period, an administration period, and a follow-up period. All subjects must sign an informed consent form before entering the screening period.

In this study, nuclear medicine physicians with tau-PET image reading experience will undergo training in the XTR006 PET visual reading methodology. Three nuclear medicine physicians who achieve excellent scores on the assessment will be selected as blinded visual readers for this study. All subject images will be visually interpreted in a blinded manner according to the XTR006 PET visual reading methodology. The final reading conclusion will be determined by consensus of at least two blinded visual readers. Using the composite diagnostic results of clinical cognitive assessment and Aβ-PET examination as the reference standard, sensitivity and specificity will be calculated with their 95% confidence intervals. The primary endpoint of this study will be considered achieved if the lower limit of the confidence interval exceeds the target value of 60%. Additionally, this study will analyze PET SUVR across groups to evaluate XTR006 uptake characteristics in different populations from a semi-quantitative perspective and assess the safety of XTR006 through analysis of post-administration AEs and SAEs.