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RECRUITING
NCT07115238
PHASE3

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

Sponsor: Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

354

Start Date

2024-11-20

Completion Date

2026-06-30

Last Updated

2025-08-11

Healthy Volunteers

Yes

Interventions

DRUG

XTR006

all patients will receive one injection of \[18F\]XTR006, a PET radiopharmaceutical selective for NFTs. For the injection, subjects will receive a target dose of 4-6 mCi IV as a bolus injection. \[18F\]XTR006 injection will be followed by a 10 ml saline flush.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China