An observational study in Alzheimer's Disease, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Peking Union Medical College Hospital · Observational
[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects.
Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Healthy participants of patients with probable Alzheimer's disease or with dementia due to other causes
Exclusion Criteria:
Drug: \[18F\]Florbetazine (\[18F\]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
Drug: [18F]Florbetazine ([18F]92) · Drug: [11C]PIB
Drug: \[18F\]Florbetazine (\[18F\]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
Drug: [18F]Florbetazine ([18F]92) · Drug: [11C]PIB
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer \[18F\]Florbetazine and will undergo a PET/CT scan.
Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer \[11C\]PIB and will undergo a PET/CT scan.
The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The non-displacable binding potential (BPND) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
Time frame: 1 year
The distribution volume ratio (DVR) of [18F]Florbetazine in healthy participants and patients with probable AD
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The distribution volume ratio (DVR) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
Time frame: 1 year
Comparison of the cortical and white matter binding of [18F]Florbetazine ([18F]92) with [11C]PIB in healthy participants and patients with cognitive decline
\[18F\]Florbetazine (\[18F\]92) PET and \[11C\]PIB PET will be conducted in the same subjects. standardized uptake value ratios of determined cortical and white matter regions will be calculated for both tracers and then compared.
Time frame: 2 years
Plan to share: No
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Peking Union Medical College Hospital