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

NCT07115238 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2025-08-11

No results posted yet for this study

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

Conditions

  • Alzheimer Disease
  • Neurofibrillary Tangle

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.

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    lead INDUSTRY

Principal Investigators

  • Jiong Shi, Doctor · The First Affiliated Hospital of University of Science and Technology of China

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115238 on ClinicalTrials.gov