drugset / Trial / NCT07115238

Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD

NCT07115238

Phase 3 Recruiting 354 enrolled Sinotau Pharmaceutical Group
Non-randomizedParallel-groupSingle-blindDiagnostic

Summary

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

Timeline

Start
2024-11-20
Primary completion
2025-12-31
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-MK-6240 Diagnostic / imaging agent 4 unknown Intravenous
Subject 18F-MK-6240 Diagnostic / imaging agent 6 unknown Intravenous

Indications