RecruitingPhase 3NCT07115238

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

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


Sponsor

Sinotau Pharmaceutical Group

Enrollment

354 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new experimental PET scan tracer called 18F-XTR006 to see how well it can detect tau protein buildup in the brain — a key feature of Alzheimer's disease. It will be tested in cognitively normal adults, those with early memory problems (MCI), and those with Alzheimer's disease. **You may be eligible if...** - You are 50 or older - You can tolerate both PET and MRI scans - You fall into one of three groups: cognitively normal (CDR score 0, normal memory test), mild cognitive impairment (MCI), or Alzheimer's disease — with supporting brain scan evidence **You may NOT be eligible if...** - You have another type of dementia (such as Lewy body or frontotemporal) - You have significant psychiatric illness preventing you from completing scans - You have large strokes or brain tumors shown on MRI - You have claustrophobia or a history of alcohol or drug dependence - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXTR006

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

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NCT07115238


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