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PET scan using florbetapir, MRI Scan · 1 trial · 1 indication
BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.
Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.
Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz \[Hz\]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.
DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.
DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.
| Arm | Type | Description |
|---|---|---|
| Imaging Biomarkers | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PET scan using florbetapir | OTHER | A single intravenous microdose of 260 MBq (7 mCi) 18F-AV-45 (florbetapir F 18) will be administered. |
| MRI Scan | OTHER | Three different measurements will be taken: volumetric MRI (vMRI), diffusion tensor imaging (DTI), and resting state functional MRI (rsfMRI). In addition, radiological MRI scans will be taken to monitor vasogenic edema and microhemorrhages. |
Inclusion Criteria: * Present with prodromal Alzheimer's Disease (AD) or mild AD based on the disease diagnostic criteria * Are men or post-menopausal women, at least 55 years of age. Post-menopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have b...
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A PET scan using florbetapir and an MRI scan are imaging methods studied for use in Alzheimer's Disease. These scans are used to visualize brain changes associated with the condition. The combination was evaluated in a non-drug methods study to understand their potential role in assessing participants with Alzheimer's Disease.
Eli Lilly and Company (ticker: LLY) is the developer associated with the PET scan using florbetapir and MRI scan. The company conducted a clinical study to evaluate these imaging methods in participants with Alzheimer's Disease.
The PET scan using florbetapir and MRI scan is in Phase 1 clinical development. This phase represents early-stage investigation of the imaging methods. The associated study has been completed, and the methods remain investigational for use in Alzheimer's Disease.
The PET scan using florbetapir and MRI scan was studied in clinical trial NCT01459016, titled 'A Non-drug Methods Study in Participants With Alzheimer's Disease'. This Phase 1 trial was completed in France, enrolled 56 participants aged 55 years and older, and was uncontrolled.
The PET scan using florbetapir and MRI scan is not FDA approved. It is an investigational imaging approach still in clinical development for Alzheimer's Disease. The Phase 1 study has been completed, but approval status has not been established.