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

NCT07115238 | Recruiting Phase 3

• 1 other identifier: STB-XTR006-301
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles)

  The sensitivity and specificity of XTR006 PET imaging visual reading results compared to the truth standard.

  12month

Secondary Outcomes (2)

• Compare the overall brain uptake patterns of XTR006 in MCI (Mild Cognitive Impairment), AD (Alzheimer's Disease), and cognitively normal subjects.

  12month

• Safety and Tolerability Profile Measured by Adverse Events (AEs)

  12month

Study Arms (3)

Alzheimer's Disease

EXPERIMENTAL

AD subjects will undergo PET imaging using \[18F\]XTR006.

Drug: XTR006

Mild Cognitive Impairment Due to Alzheimer's Disease

EXPERIMENTAL

MCI subjects will undergo PET imaging using \[18F\]XTR006.

Drug: XTR006

Cognitively normal

EXPERIMENTAL

Cognitively normal subjects will undergo PET imaging using \[18F\]XTR006.

Drug: XTR006

Interventions

XTR006 DRUG

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.

Also known as: [18F]MK 6240, Florquinitau

Alzheimer's Disease; Cognitively normal; Mild Cognitive Impairment Due to Alzheimer's Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥50 years.
• Able to tolerate both PET and MRI examinations.
• Must use contraceptive measures during the study period and for 6 months after study completion.
• Written informed consent must be obtained before any assessment is performed.
• )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.
• Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards
• Positive visual reading result on brain Aβ-PET imaging
• Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:
• Positive visual reading result on brain Aβ-PET imaging.

You may not qualify if:

• Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia.
• Current significant psychiatric illness with symptoms that prevent completion of imaging procedures.
• MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions.
• Claustrophobia.
• History of alcohol abuse or drug abuse/dependence.
• Allergy to the study drug or any of its components.
• Women who are currently breastfeeding.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jiong Shi, Doctor

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Shi, Doctor

CONTACT

15512191857; jshi2022@ystc.edu.cn

Ruiming Wang, Doctor

CONTACT

13501151740; wrm@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: November 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)