Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated August 11, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07115238
Lead Sponsor Sinotau Pharmaceutical Group
Conditions Alzheimer Disease, Neurofibrillary Tangle
Enrollment 354 participants
Start Date 2024-11-20
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-11