Ireland
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Recruiting Phase 3

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

NCT07115238 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-11-20
Last updated
2025-08-11

Condition(s) studied

Alzheimer DiseaseNeurofibrillary Tangle

Investigational drug(s) / intervention(s)

XTR006

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.

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Inclusion Criteria for All Subjects: 1. Male or female subjects aged ≥50 years. 2. Able to tolerate both PET and MRI examinations. 3. Must use contraceptive measures during the study period and for 6 months after study completion. 4. Written informed consent must be obtained before any assessment is performed. Inclusion Criteria for Cognitively Normal Subjects: 1)CDR (Clinical Dementia Rating) score of 0. 2)MMSE (Mini-Mental State Examination) score ≥28. 3)Negative visual reading result on brain Aβ-PET imaging. Inclusion Criteria for Subjects with MCI: 1. Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards 2. Positive visual reading result on brain Aβ-PET imaging Inclusion Criteria for Subjects with AD: 1. Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards: 2. Positive visual reading result on brain Aβ-PET imaging. Exclusion Criteria: 1. Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia. 2. Current significant psychiatric illness with symptoms that prevent completion of imaging procedures. 3. MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions. 4. Claustrophobia. 5. History of alcohol abuse or drug abuse/dependence. 6. Allergy to the study drug or any of its components. 7. Women who are currently breastfeeding.

Primary outcome measure(s)

  • Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles) — 12month
    The sensitivity and specificity of XTR006 PET imaging visual reading results compared to the truth standard.

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07115238 on ClinicalTrials.gov ↗ ← All trials in China