A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \[18F\]Fluorbetazine injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
normal cognitive function, mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) using \[18F\]Fluorbetazine injection.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of \[18F\]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
Time frame: 1 year
1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dem
1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dementia participants and cognitively normal participants, and determine the diagnostic performance of SUVR;
Time frame: 1year
2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall
2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall
Time frame: 1year
3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.
3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.
Time frame: 1year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.