Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD (NCT07115238) | Clinical Trial Compass
RecruitingPhase 3
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
China354 participantsStarted 2024-11-20
Plain-language 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
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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 criteria
✕. Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia.
What they're measuring
1
Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles)