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.
None
Known allergy to [18F]Fluorbetazine injection or its excipients.
Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons.
Cognitive impairment caused by reasons other than Alzheimer's disease (AD).
More than 2 infarctions with a diameter greater than 2 cm in any part of the brain;
Single group
[18F]Fluorbetazine injection
Drugnormal cognitive function, mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) using \[18F\]Fluorbetazine injection.
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.
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.
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;
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
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.
The safety assessment is based on serious adverse events, adverse events
Serious adverse events and adverse events during the research period;
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