Actively Recruiting
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
Led by Sinotau Pharmaceutical Group · Updated on 2025-08-11
354
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 50 years or older
- Able to tolerate both PET and MRI examinations
- Must use contraceptive measures during the study and for 6 months after study completion
- Signed written informed consent before any assessments
- Cognitively normal subjects must have a Clinical Dementia Rating (CDR) score of 0
- Cognitively normal subjects must have a Mini-Mental State Examination (MMSE) score of 28 or higher
- Cognitively normal subjects must have a negative visual reading on brain Ab2-PET imaging
- Subjects with Mild Cognitive Impairment (MCI) must meet 2011 NIA-AA core clinical criteria for MCI due to Alzheimer's Disease
- Subjects with MCI must have a positive visual reading on brain Ab2-PET imaging
- Subjects with Alzheimer's Disease (AD) must meet 2014 International Working Group (IWG)-2 clinical phenotype criteria for typical AD
- Subjects with AD must have a positive visual reading on brain Ab2-PET imaging
You will not qualify if you...
- Diagnosis of atypical Alzheimer's Disease, frontotemporal lobar degeneration, Lewy body dementia, or other types of dementia
- Current significant psychiatric illness preventing completion of imaging procedures
- MRI-confirmed structural brain abnormalities such as large stroke or intracranial mass lesions
- Claustrophobia
- History of alcohol or drug abuse or dependence
- Allergy to the study drug or its components
- Women who are currently breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100089
Actively Recruiting
Research Team
J
Jiong Shi, Doctor
CONTACT
R
Ruiming Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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