Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01459016 | A Non-drug Methods Study in Participants With Alzheimer's Disease | PHASE1 | COMPLETED | 56 | — | — | Dec 1, 2011 | Dec 1, 2014 | Jun 28, 2018 | 16 | France |
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...