Trial Outcomes & Findings for A Non-drug Methods Study in Participants With Alzheimer's Disease (NCT NCT01459016)
NCT ID: NCT01459016
Last Updated: 2018-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Baseline, 6 Mos; Baseline, 12 Mos
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
Standard of Care
Participants with prodromal to mild Alzheimer's Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) \[7 to 10 millicuries (mCi)\] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Standard of Care
Participants with prodromal to mild Alzheimer's Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) \[7 to 10 millicuries (mCi)\] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Amendment Discontinuation Criteria
|
4
|
Baseline Characteristics
A Non-drug Methods Study in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
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.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
BBSI - 6 Mos
|
6.349 milliliters (mL)
Interval 3.735 to 8.963
|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
BBSI - 12 Mos
|
11.663 milliliters (mL)
Interval 8.608 to 14.719
|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
VBSI - 6 Mos
|
2.016 milliliters (mL)
Interval 1.361 to 2.671
|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
VBSI - 12 Mos
|
4.196 milliliters (mL)
Interval 3.088 to 5.303
|
PRIMARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)
Hippocampus Volume Average % Chg - 6 Mos
|
-1.693 percentage of hippocampus volume average
Interval -2.273 to -1.113
|
|
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)
Hippocampus Volume Average % Chg - 12 Mos
|
-3.057 percentage of hippocampus volume average
Interval -3.884 to -2.231
|
PRIMARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
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.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
SN - 6 Mos
|
-0.021 arbitrary units (au)
Interval -0.048 to 0.005
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Anterior DMN - 6 Mos
|
0.017 arbitrary units (au)
Interval -0.033 to 0.067
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Anterior DMN - 12 Mos
|
0.031 arbitrary units (au)
Interval -0.017 to 0.08
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Anterior SN - 6 Mos
|
-0.012 arbitrary units (au)
Interval -0.043 to 0.019
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Anterior SN -12 Mos
|
-0.025 arbitrary units (au)
Interval -0.065 to 0.014
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
DMN - 6 Mos
|
-0.029 arbitrary units (au)
Interval -0.06 to 0.001
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
DMN - 12 Mos
|
-0.031 arbitrary units (au)
Interval -0.061 to -0.001
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Posterior DMN - 6 Mos
|
-0.061 arbitrary units (au)
Interval -0.12 to -0.002
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Posterior DMN - 12 Mos
|
-0.058 arbitrary units (au)
Interval -0.096 to -0.021
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Posterior SN - 6 Mos
|
-0.012 arbitrary units (au)
Interval -0.045 to 0.021
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Posterior SN - 12 Mos
|
0.001 arbitrary units (au)
Interval -0.04 to 0.043
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
SN - 12 Mos
|
-0.008 arbitrary units (au)
Interval -0.043 to 0.027
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
SMN - 6 Mos
|
0.041 arbitrary units (au)
Interval 0.009 to 0.072
|
|
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
SMN - 12 Mos
|
-0.013 arbitrary units (au)
Interval -0.06 to 0.034
|
PRIMARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
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.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, IC (Right) - 6 Mos
|
-0.046 au
Interval -0.067 to -0.025
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, PCB (Left) - 6 Mos
|
0.000 au
Interval -0.012 to 0.013
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, TWM (Right) - 6 Mos
|
-0.014 au
Interval -0.022 to -0.005
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, TWM (Right) - 12 Mos
|
-0.009 au
Interval -0.019 to 0.001
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, CC (Genu) - 6 Mos
|
-0.024 au
Interval -0.046 to -0.003
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, CC (Genu) - 12 Mos
|
-0.021 au
Interval -0.041 to -0.001
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, CC (Splenium) - 6 Mos
|
-0.016 au
Interval -0.043 to 0.012
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, CC (Splenium) - 12 Mos
|
0.009 au
Interval -0.026 to 0.043
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, IC (Left) - 6 Mos
|
-0.043 au
Interval -0.066 to -0.02
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, IC (Left) - 12 Mos
|
-0.020 au
Interval -0.043 to 0.003
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, IC (Right) - 12 Mos
|
-0.020 au
Interval -0.038 to -0.002
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, PCB (Left) - 12 Mos
|
0.010 au
Interval 0.003 to 0.017
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, PCB (Right) - 6 Mos
|
0.010 au
Interval -0.001 to 0.021
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, PCB (Right) - 12 Mos
|
0.003 au
Interval -0.008 to 0.015
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, TWM (Left) - 6 Mos
|
-0.017 au
Interval -0.028 to -0.006
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, TWM (Left) - 12 Mos
|
-0.011 au
Interval -0.022 to 0.0
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, UF (Left) - 6 Mos
|
-0.027 au
Interval -0.045 to -0.01
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, UF (Left) - 12 Mos
|
0.010 au
Interval -0.007 to 0.027
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, UF (Right) - 6 Mos
|
-0.032 au
Interval -0.049 to -0.015
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, UF (Right) - 12 Mos
|
0.005 au
Interval -0.009 to 0.02
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, SLF (Left) - 6 Mos
|
-0.014 au
Interval -0.025 to -0.003
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, SLF (Left) - 12 Mos
|
-0.003 au
Interval -0.014 to 0.007
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, SLF (Right) - 6 Mos
|
-0.006 au
Interval -0.019 to 0.007
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Mean FA, SLF (Right) - 12 Mos
|
0.002 au
Interval -0.009 to 0.012
|
PRIMARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
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.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, UF (Left) - 6 Mos
|
-0.150 square meters per second (m²/sec) * 10¹⁰
Interval -0.518 to 0.218
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, UF (Left) - 12 Mos
|
-0.600 square meters per second (m²/sec) * 10¹⁰
Interval -1.005 to -0.196
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, UF (Right) - 6 Mos
|
0.240 square meters per second (m²/sec) * 10¹⁰
Interval -0.2 to 0.681
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, CC (Genu) - 6 Mos
|
0.201 square meters per second (m²/sec) * 10¹⁰
Interval -0.157 to 0.559
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, CC (Genu) - 12 Mos
|
0.761 square meters per second (m²/sec) * 10¹⁰
Interval -0.28 to 1.802
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, CC (Splenium) - 6 Mos
|
0.663 square meters per second (m²/sec) * 10¹⁰
Interval -0.114 to 1.44
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, CC (Splenium) - 12 Mos
|
-0.519 square meters per second (m²/sec) * 10¹⁰
Interval -0.956 to -0.082
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, IC (Left) - 6 Mos
|
0.410 square meters per second (m²/sec) * 10¹⁰
Interval 0.043 to 0.777
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, IC (Left) - 12 Mos
|
0.164 square meters per second (m²/sec) * 10¹⁰
Interval -0.107 to 0.435
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, IC (Right) - 6 Mos
|
0.441 square meters per second (m²/sec) * 10¹⁰
Interval 0.203 to 0.679
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, IC (Right) - 12 Mos
|
0.280 square meters per second (m²/sec) * 10¹⁰
Interval 0.12 to 0.44
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, PCB (Left) - 6 Mos
|
-0.062 square meters per second (m²/sec) * 10¹⁰
Interval -0.326 to 0.203
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, PCB (Left) - 12 Mos
|
0.175 square meters per second (m²/sec) * 10¹⁰
Interval -0.087 to 0.436
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, PCB (Right) - 6 Mos
|
0.114 square meters per second (m²/sec) * 10¹⁰
Interval -0.156 to 0.385
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, PCB (Right) - 12 Mos
|
0.297 square meters per second (m²/sec) * 10¹⁰
Interval 0.053 to 0.541
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD TWM (Left) - 6 Mos
|
-0.014 square meters per second (m²/sec) * 10¹⁰
Interval -0.28 to 0.251
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD TWM (Left) - 12 Mos
|
-0.010 square meters per second (m²/sec) * 10¹⁰
Interval -0.295 to 0.274
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD TWM (Right) - 6 Mos
|
0.243 square meters per second (m²/sec) * 10¹⁰
Interval -0.047 to 0.533
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD TWM (Right) - 12 Mos
|
0.285 square meters per second (m²/sec) * 10¹⁰
Interval 0.077 to 0.493
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD, UF (Right) - 12 Mos
|
-0.289 square meters per second (m²/sec) * 10¹⁰
Interval -0.649 to 0.072
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD SLF (Left) - 6 Mos
|
0.083 square meters per second (m²/sec) * 10¹⁰
Interval -0.07 to 0.237
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD SLF (Left) - 12 Mos
|
-0.007 square meters per second (m²/sec) * 10¹⁰
Interval -0.108 to 0.094
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD SLF (Right) - 6 Mos
|
0.085 square meters per second (m²/sec) * 10¹⁰
Interval -0.113 to 0.284
|
|
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Mean MD SLF (Right) - 12 Mos
|
0.097 square meters per second (m²/sec) * 10¹⁰
Interval -0.004 to 0.197
|
SECONDARY outcome
Timeframe: BaselinePopulation: All participants with an amyloid positive florbetapir F 18 PET scan at baseline.
Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir
|
1.581 SUVR unit 1
Standard Deviation 0.200
|
SECONDARY outcome
Timeframe: BaselinePopulation: All participants who had an MRI during screening and were classified as screen failures.
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and had an evaluable MRI at the designated time point.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T
Baseline
|
16 Participants
|
|
Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T
6 Mos
|
12 Participants
|
|
Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T
12 Mos
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and completed the scale at the designated time point.
The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in the Mini Mental State Examination (MMSE) Total Score
6 Mos
|
-1.2 units on a scale
Interval -2.0 to -0.5
|
|
Change From Baseline in the Mini Mental State Examination (MMSE) Total Score
12 Mos
|
-1.8 units on a scale
Interval -2.7 to -0.8
|
SECONDARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and completed the scale at the designated time point.
The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score
6 Mos
|
0.1 units on a scale
Interval -1.6 to 1.8
|
|
Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score
12 Mos
|
0.7 units on a scale
Interval -1.7 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, 6 Mos; Baseline, 12 MosPopulation: All participants who enrolled in the study and completed the scale at the designated time point.
The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.
Outcome measures
| Measure |
Standard of Care
n=56 Participants
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Change From Baseline in the Clinical Dementia Rating (CDR) Total Score
6 Mos
|
0.1 units on a scale
Interval 0.0 to 0.2
|
|
Change From Baseline in the Clinical Dementia Rating (CDR) Total Score
12 Mos
|
0.1 units on a scale
Interval 0.0 to 0.2
|
Adverse Events
Standard of Care
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=56 participants at risk
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Gastrointestinal disorders
Oesophagitis
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Dementia alzheimer's type
|
1.8%
1/56 • Number of events 1
|
Other adverse events
| Measure |
Standard of Care
n=56 participants at risk
Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq \[7 to 10 mCi\] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
|
|---|---|
|
Nervous system disorders
Dementia alzheimer's type
|
17.9%
10/56 • Number of events 10
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60