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
The goal of this clinical trial is to evaluate the efficacy and safety of XTR006 injection PET visual reading in detecting brain neurofibrillary tangles (NFTs) in elderly subjects with Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), and cognitively normal individuals. The main question it aims to answer is: • What is the sensitivity and specificity of XTR006 PET visual reading results compared to the truth standard across MCI, AD, and cognitively normal subjects? Participants will: * Receive XTR006 injection * Undergo PET/CT scanning
⁃ Male or female subjects aged ≥50 years.
⁃ Able to tolerate both PET and MRI examinations.
⁃ Must use contraceptive measures during the study period and for 6 months after study completion.
⁃ Written informed consent must be obtained before any assessment is performed.
• CDR (Clinical Dementia Rating) score of 0. 2）MMSE (Mini-Mental State Examination) score ≥28. 3）Negative visual reading result on brain Aβ-PET imaging.
⁃ Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards
⁃ Positive visual reading result on brain Aβ-PET imaging
⁃ Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:
⁃ Positive visual reading result on brain Aβ-PET imaging.