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

Alzheimer Disease Neurofibrillary Tangle

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

Inclusion Criteria9

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.

Exclusion Criteria7

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.

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.