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

NCT ID: NCT07115238

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2026-06-30

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

Detailed Description

This is a multicenter, single-blind, non-randomized phase III study. The study aims to evaluate the effectiveness of XTR006 PET imaging visual reads for detecting NFTs in subjects. The trial procedures for all subjects include a screening period, an administration period, and a follow-up period. All subjects must sign an informed consent form before entering the screening period.

In this study, nuclear medicine physicians with tau-PET image reading experience will undergo training in the XTR006 PET visual reading methodology. Three nuclear medicine physicians who achieve excellent scores on the assessment will be selected as blinded visual readers for this study. All subject images will be visually interpreted in a blinded manner according to the XTR006 PET visual reading methodology. The final reading conclusion will be determined by consensus of at least two blinded visual readers. Using the composite diagnostic results of clinical cognitive assessment and Aβ-PET examination as the reference standard, sensitivity and specificity will be calculated with their 95% confidence intervals. The primary endpoint of this study will be considered achieved if the lower limit of the confidence interval exceeds the target value of 60%. Additionally, this study will analyze PET SUVR across groups to evaluate XTR006 uptake characteristics in different populations from a semi-quantitative perspective and assess the safety of XTR006 through analysis of post-administration AEs and SAEs.

Conditions

Alzheimer Disease; Neurofibrillary Tangle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Alzheimer's Disease

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

Group Type: EXPERIMENTAL

XTR006

Intervention Type: 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.

Mild Cognitive Impairment Due to Alzheimer's Disease

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

Group Type: EXPERIMENTAL

XTR006

Intervention Type: 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.

Cognitively normal

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

Group Type: EXPERIMENTAL

XTR006

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

[18F]MK 6240; Florquinitau

Eligibility Criteria

Inclusion Criteria

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.

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.

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

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiong Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiong Shi, Doctor

Role: CONTACT

jshi2022@ystc.edu.cn

15512191857

Ruiming Wang, Doctor

Role: CONTACT

wrm@yeah.net

13501151740

Facility Contacts

Ruiming PG Wang, Doctor

Role: primary

wrm@yeah.net

13501151740

Other Identifiers

STB-XTR006-301

Identifier Type: -

Identifier Source: org_study_id