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Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

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ClinicalTrials.gov Identifier: NCT00667810
Recruitment Status : Terminated (The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
First Posted : April 28, 2008
Results First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Drug: bapineuzumab
Drug: placebo
Enrollment 901
Recruitment Details The study was terminated on 06 August 2012 due to lack of clinical efficacy observed in completed studies ELN115727-301 (ApoE4 non-carriers) and ELN115727-302. A total of 329 participants had completed the study up to and including Week 78 before the decision was taken to terminate the study.
Pre-assignment Details The study originally included bapineuzumab 2.0 mg/kg dose level, which was discontinued on 02 April 2009 based on input from independent safety monitoring committee. It was estimated at the time that about 10 participants received 2.0mg/kg. These participants are not included in the efficacy analyses.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Period Title: Overall Study
Started 269 264 346 11
Treated 267 263 344 11
Completed 102 94 124 9
Not Completed 167 170 222 2
Reason Not Completed
Adverse Event             13             14             19             1
Death             1             1             3             0
Lack of Efficacy             1             0             2             0
Lost to Follow-up             1             4             2             0
Physician Decision             1             1             2             0
Protocol Violation             0             2             0             0
Withdrawal by Subject             14             20             29             1
Discontinuation of Study by Sponsor             130             118             155             0
Failed to Return             0             0             2             0
Loss of Caregiver             0             1             3             0
Vasogenic Edema Recurrence             0             3             0             0
Not specified             6             6             5             0
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg Total
Hide Arm/Group Description Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Total of all reporting groups
Overall Number of Baseline Participants 267 263 344 11 885
Hide Baseline Analysis Population Description
Safety population included all randomized participants who received at least one infusion or portion of an infusion of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 267 participants 263 participants 344 participants 11 participants 885 participants
71.4  (9.38) 70.8  (9.73) 69.9  (9.76) 66.5  (7.94) 70.6  (9.63)
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 267 participants 263 participants 344 participants 11 participants 885 participants
<65 years 73 81 115 6 275
≥65 years 194 182 229 5 610
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 263 participants 344 participants 11 participants 885 participants
Female
151
  56.6%
150
  57.0%
199
  57.8%
4
  36.4%
504
  56.9%
Male
116
  43.4%
113
  43.0%
145
  42.2%
7
  63.6%
381
  43.1%
1.Primary Outcome
Title The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
Hide Description The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
Time Frame 78 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.05  (0.71) 8.07  (0.73) 7.88  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.83
Confidence Interval (2-Sided) 95%
-3.71 to 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-1.73 to 2.10
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
Hide Description The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.
Time Frame 78 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-14.58  (1.50) -15.07  (1.55) -16.08  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
-2.48 to 5.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
-3.04 to 5.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Change From Baseline in Brain Amyloid Burden at Week 71.
Hide Description Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.
Time Frame 71 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Pooled Bapineuzumab 0.5/1.0 mg/kg
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
Overall Number of Participants Analyzed 6 11 13 17
Least Squares Mean (Standard Error)
Unit of Measure: SUVr
-0.04  (0.08) 0.00  (0.05) 0.02  (0.04) -0.01  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled Bapineuzumab 0.5/1.0 mg/kg
Comments The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.15 to 0.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
Hide Description Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.
Time Frame 71 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Pooled Bapineuzumab 0.5/1.0 mg/kg
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
Overall Number of Participants Analyzed 21 22 33 43
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
-6.62  (3.90) -6.35  (3.73) 0.70  (3.03) -6.48  (2.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled Bapineuzumab 0.5/1.0 mg/kg
Comments The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.18
Confidence Interval (2-Sided) 95%
-15.38 to 1.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Change From Baseline in Brain Volume at Week 71
Hide Description Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.
Time Frame 71 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 122 121 153
Least Squares Mean (Standard Error)
Unit of Measure: mL/year
18.55  (0.97) 18.60  (1.00) 17.54  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
-1.55 to 3.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.423
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
-1.54 to 3.66
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
Hide Description The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.
Time Frame 39 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg - Placebo Bapineuzumab 1.0 mg/kg - Placebo
Hide Arm/Group Description:
For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
Overall Number of Participants Analyzed 583 581
Mean (Standard Error)
Unit of Measure: Units/Year
-1.32  (1.06) 0.38  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg - Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-3.40 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg - Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-1.76 to 2.52
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Hide Description The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.
Time Frame 39 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg - Placebo Bapineuzumab 1.0 mg/kg - Placebo
Hide Arm/Group Description:
For the DAD total score, results are presented from a REML-based MMRM.
For the DAD total score, results are presented from a REML)-based MMRM.
Overall Number of Participants Analyzed 583 581
Mean (Standard Error)
Unit of Measure: Units/Years
3.20  (2.22) 2.01  (2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg - Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.20
Confidence Interval (2-Sided) 95%
-1.15 to 7.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg - Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.01
Confidence Interval (2-Sided) 95%
-2.44 to 6.46
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Hide Description The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Median (95% Confidence Interval)
Unit of Measure: Days
546.0 [1] 
(546.0 to NA)
462.0
(455.0 to 546.0)
540.0
(462.0 to 546.0)
[1]
Value was not calculable due to the large number of censored event times
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Not specifed.
Method Log Rank
Comments Not specified.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments Not specified.
Method Log Rank
Comments Not specified.
9.Secondary Outcome
Title Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
Hide Description The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.
Time Frame 78 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Median (95% Confidence Interval)
Unit of Measure: Days
546.0 [1] 
(546.0 to NA)
546.0
(455.0 to 546.0)
546.0
(476.0 to 546.0)
[1]
Values were not calculable due to the large number of censored event times
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments Not specified.
Method Log Rank
Comments Not specified.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.675
Comments Not specified.
Method Log Rank
Comments [Not Specified]
10.Secondary Outcome
Title Time to Median Placebo Deterioration on DAD Total Score
Hide Description The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Median (95% Confidence Interval)
Unit of Measure: Days
541.0
(455.0 to 546.0)
534.0 [1] 
(372.0 to NA)
463.0
(453.0 to 546.0)
[1]
Values were not calculable due to the large number of censored event times
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not spsecified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments Not specified.
Method Log Rank
Comments Not specified.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.797
Comments Not specified
Method Log Rank
Comments Not specified.
11.Secondary Outcome
Title Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
Hide Description The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Median (95% Confidence Interval)
Unit of Measure: Days
542.0
(456.0 to 546.0)
539.0 [1] 
(450.0 to NA)
540.0
(453.0 to 546.0)
[1]
Value was not calculable due to the large number of censored event times
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments Not specified.
Method Log Rank
Comments Not specified.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments Not specified.
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
Hide Description Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number of participants
Worsening of 0 points
10.6
(7.1 to 15.0)
8.7
(5.5 to 12.9)
7.3
(4.7 to 10.7)
Worsening of 3 points
16.1
(11.8 to 21.2)
13.4
(9.5 to 18.3)
10.1
(7.0 to 13.8)
Worsening of 7 points
23.1
(18.1 to 28.8)
19.0
(14.3 to 24.4)
19.2
(15.1 to 23.9)
13.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Hide Description Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Measure Type: Number
Unit of Measure: Percentage of participants
22.4 18.6 18.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments Not specified.
Method Cochran-Mantel-Haenszel
Comments Not specified.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments Not specified.
Method Cochran-Mantel-Haenszel
Comments Not specified.
14.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
Hide Description Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Worsening of 0 points
10.2
(6.8 to 14.6)
11.9
(8.1 to 16.5)
9.1
(6.3 to 12.8)
Worsening of 6 points
15.7
(11.4 to 20.7)
16.6
(12.2 to 21.8)
14.3
(10.7 to 18.6)
Worsening of 12 points
20.0
(15.3 to 25.4)
22.1
(17.2 to 27.8)
19.5
(15.4 to 24.2)
15.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
Hide Description Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.
Time Frame 78 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 22.1 19.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.855
Comments Not specified.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Not specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.423
Comments Not specified.
Method Cochran-Mantel-Haenszel
Comments Not specified.
16.Secondary Outcome
Title Change From Baseline in Dependence Scale Total Score at Week 78
Hide Description The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.29  (0.19) 1.16  (0.19) 1.45  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Change in DS score was analyzed using a REML based MMRM.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.516
Comments Not specified.
Method Mixed Models Analysis
Comments Not specified.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.65 to 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Change in DS score was analyzed using a REML based MMRM.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.79 to 0.21
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
Hide Description The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.
Time Frame 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
Overall Number of Participants Analyzed 255 253 328
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.23  (0.23) 2.41  (0.23) 2.59  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 0.5 mg/kg, Placebo
Comments Change in CDR-SOB total score was analyzed using a REML based MMRM.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments Not specified.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.96 to 0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bapineuzumab 1.0 mg/kg, Placebo
Comments Change in CDR-SOB total score was analyzed using a REML based MMRM.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.564
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.78 to 0.43
Estimation Comments [Not Specified]
Time Frame 4 years
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion. Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
All-Cause Mortality
Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/267 (11.99%)      34/263 (12.93%)      53/344 (15.41%)      2/11 (18.18%)    
Blood and lymphatic system disorders         
Anaemia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Iron deficiency anaemia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Cardiac disorders         
Acute left ventricular failure  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Acute myocardial infarction  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Adams-Stokes syndrome  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Angina pectoris  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Atrial fibrillation  1  1/267 (0.37%)  1 1/263 (0.38%)  2 0/344 (0.00%)  0 0/11 (0.00%)  0
Bradycardia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Cardiac failure congestive  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Coronary artery disease  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Myocardial infarction  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Eye disorders         
Cataract  1  0/267 (0.00%)  0 1/263 (0.38%)  3 0/344 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Diarrhoea  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Faecal incontinence  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Gastritis  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Intestinal ischaemia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Nausea  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Vomiting  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
General disorders         
Death  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
General physical health deterioration  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Granuloma  1  0/267 (0.00%)  0 1/263 (0.38%)  2 0/344 (0.00%)  0 0/11 (0.00%)  0
Infections and infestations         
Anal abscess  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Appendicitis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Bacteraemia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Bronchopneumonia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Clostridium difficile colitis  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Escherichia bacteraemia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Herpes zoster oticus  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Lower respiratory tract infection  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Meningitis viral  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Otitis media  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Periorbital cellulitis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Pneumonia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Pyelonephritis  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Respiratory tract infection  1  0/267 (0.00%)  0 1/263 (0.38%)  1 1/344 (0.29%)  1 0/11 (0.00%)  0
Sepsis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Urinary tract infection  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Urosepsis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Heat illness  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Clavicle fracture  1  1/267 (0.37%)  1 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Fall  1  0/267 (0.00%)  0 1/263 (0.38%)  1 2/344 (0.58%)  2 0/11 (0.00%)  0
Femoral neck fracture  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Femur fracture  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Hip fracture  1  1/267 (0.37%)  1 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Humerus fracture  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Jaw fracture  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Joint dislocation  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Multiple injuries  1  2/267 (0.75%)  2 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Overdose  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Radius fracture  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  2 0/11 (0.00%)  0
Rib fracture  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Skull fractured base  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Spinal compression fracture  1  1/267 (0.37%)  1 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Spinal fracture  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Subdural haematoma  1  0/267 (0.00%)  0 1/263 (0.38%)  1 2/344 (0.58%)  2 0/11 (0.00%)  0
Subdural haemorrhage  1  1/267 (0.37%)  1 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Tendon rupture  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Upper limb fracture  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Investigations         
ECG signs of myocardial ischaemia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Liver function test abnormal  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Weight decreased  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Dehydration  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Hypokalaemia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Osteoarthritis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Pain in extremity  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Spinal osteoarthritis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Adenocarcinoma pancreas  1  1/267 (0.37%)  3 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Basal cell carcinoma  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Breast cancer  1  1/267 (0.37%)  2 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Colorectal cancer  1  0/267 (0.00%)  0 0/263 (0.00%)  0 2/344 (0.58%)  4 0/11 (0.00%)  0
Gastric cancer  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Glioblastoma  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Keratoacanthoma  1  1/267 (0.37%)  2 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Lung neoplasm malignant  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  2 0/11 (0.00%)  0
Malignant melanoma  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Metastases to central nervous system  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Metastases to liver  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Metastases to lung  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Prostate cancer  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Rectal cancer  1  0/267 (0.00%)  0 0/263 (0.00%)  0 2/344 (0.58%)  2 0/11 (0.00%)  0
Renal cancer  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Squamous cell carcinoma  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Nervous system disorders         
Aphasia  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Cerebral infarction  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Cerebral microhaemorrhage  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 1/11 (9.09%)  3
Cerebrovascular accident  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Convulsion  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Dementia Alzheimer's type  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Dizziness  1  1/267 (0.37%)  1 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Epilepsy  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Headache  1  2/267 (0.75%)  2 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Intracranial hypotension  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Ischaemic stroke  1  0/267 (0.00%)  0 1/263 (0.38%)  1 1/344 (0.29%)  1 0/11 (0.00%)  0
Loss of consciousness  1  1/267 (0.37%)  1 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Perineurial cyst  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Presyncope  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Quadriparesis  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Radiculopathy  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Senile dementia  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Status epilepticus  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Subarachnoid haemorrhage  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Subdural hygroma  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Syncope  1  1/267 (0.37%)  1 1/263 (0.38%)  1 1/344 (0.29%)  1 0/11 (0.00%)  0
Vasogenic cerebral oedema  1  6/267 (2.25%)  8 12/263 (4.56%)  20 0/344 (0.00%)  0 2/11 (18.18%)  7
Psychiatric disorders         
Abnormal behaviour  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  2 0/11 (0.00%)  0
Aggression  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Agitation  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Alcohol abuse  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Alcoholic psychosis  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Confusional state  1  0/267 (0.00%)  0 1/263 (0.38%)  1 1/344 (0.29%)  1 1/11 (9.09%)  3
Delirium  1  0/267 (0.00%)  0 1/263 (0.38%)  1 1/344 (0.29%)  1 0/11 (0.00%)  0
Depression  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Hallucination  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Impulsive behaviour  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Jealous delusion  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Suicide attempt  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Renal and urinary disorders         
Renal failure acute  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Reproductive system and breast disorders         
Prostatitis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Dyspnoea  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Nasal polyps  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Organising pneumonia  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Pneumothorax  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Pulmonary embolism  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythema  1  0/267 (0.00%)  0 0/263 (0.00%)  0 2/344 (0.58%)  5 0/11 (0.00%)  0
Pruritus  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  4 0/11 (0.00%)  0
Urticaria  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 0/11 (0.00%)  0
Deep vein thrombosis  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 0/11 (0.00%)  0
Vascular disorders         
Aortic stenosis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Aortic thrombosis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Peripheral artery stenosis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Placebo Bapineuzumab 2.0 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/267 (40.82%)      123/263 (46.77%)      124/344 (36.05%)      9/11 (81.82%)    
Cardiac disorders         
Tachycardia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 2/344 (0.58%)  2 1/11 (9.09%)  1
Ear and labyrinth disorders         
Hypoacusis  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Eye disorders         
Vision blurred  1  0/267 (0.00%)  0 1/263 (0.38%)  4 1/344 (0.29%)  1 1/11 (9.09%)  1
Gastrointestinal disorders         
Constipation  1  6/267 (2.25%)  16 6/263 (2.28%)  6 9/344 (2.62%)  10 1/11 (9.09%)  1
Diarrhoea  1  8/267 (3.00%)  8 7/263 (2.66%)  7 11/344 (3.20%)  15 1/11 (9.09%)  1
Vomiting  1  9/267 (3.37%)  11 9/263 (3.42%)  11 10/344 (2.91%)  12 3/11 (27.27%)  3
General disorders         
Catheter site haematoma  1  0/267 (0.00%)  0 1/263 (0.38%)  2 0/344 (0.00%)  0 1/11 (9.09%)  2
Infections and infestations         
Nasopharyngitis  1  17/267 (6.37%)  23 18/263 (6.84%)  24 28/344 (8.14%)  44 2/11 (18.18%)  2
Sinusitis  1  5/267 (1.87%)  16 3/263 (1.14%)  3 3/344 (0.87%)  5 1/11 (9.09%)  12
Urinary tract infection  1  15/267 (5.62%)  17 13/263 (4.94%)  17 9/344 (2.62%)  13 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion  1  6/267 (2.25%)  7 8/263 (3.04%)  10 1/344 (0.29%)  1 2/11 (18.18%)  3
Fall  1  18/267 (6.74%)  25 16/263 (6.08%)  18 18/344 (5.23%)  26 1/11 (9.09%)  1
Investigations         
Blood pressure increased  1  5/267 (1.87%)  5 5/263 (1.90%)  9 6/344 (1.74%)  7 2/11 (18.18%)  3
Metabolism and nutrition disorders         
Hypophagia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  4
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/267 (2.25%)  15 5/263 (1.90%)  17 6/344 (1.74%)  9 1/11 (9.09%)  5
Musculoskeletal stiffness  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders         
Aphasia  1  1/267 (0.37%)  1 2/263 (0.76%)  4 2/344 (0.58%)  6 1/11 (9.09%)  1
Ataxia  1  2/267 (0.75%)  2 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Balance disorder  1  0/267 (0.00%)  0 1/263 (0.38%)  1 0/344 (0.00%)  0 1/11 (9.09%)  1
Cerebral microhaemorrhage  1  11/267 (4.12%)  13 22/263 (8.37%)  41 9/344 (2.62%)  21 1/11 (9.09%)  9
Disturbance in attention  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Dizziness  1  8/267 (3.00%)  8 7/263 (2.66%)  20 16/344 (4.65%)  17 1/11 (9.09%)  5
Dizziness postural  1  0/267 (0.00%)  0 0/263 (0.00%)  0 1/344 (0.29%)  2 1/11 (9.09%)  1
Exertional headache  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Headache  1  17/267 (6.37%)  19 15/263 (5.70%)  36 29/344 (8.43%)  36 2/11 (18.18%)  9
Hyporeflexia  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Mental impairment  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  5
Paraesthesia  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Parkinson's disease  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  5
Vasogenic cerebral oedema  1  7/267 (2.62%)  16 20/263 (7.60%)  43 2/344 (0.58%)  7 0/11 (0.00%)  0
Psychiatric disorders         
Confusional state  1  4/267 (1.50%)  4 3/263 (1.14%)  5 6/344 (1.74%)  6 1/11 (9.09%)  3
Depression  1  13/267 (4.87%)  25 11/263 (4.18%)  21 9/344 (2.62%)  24 2/11 (18.18%)  9
Hallucination  1  2/267 (0.75%)  2 2/263 (0.76%)  2 2/344 (0.58%)  2 1/11 (9.09%)  1
Psychotic disorder  1  1/267 (0.37%)  1 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  2
Skin and subcutaneous tissue disorders         
Petechiae  1  0/267 (0.00%)  0 0/263 (0.00%)  0 0/344 (0.00%)  0 1/11 (9.09%)  1
Vascular disorders         
Hypertension  1  8/267 (3.00%)  8 10/263 (3.80%)  12 9/344 (2.62%)  16 2/11 (18.18%)  9
Hypotension  1  1/267 (0.37%)  1 1/263 (0.38%)  1 0/344 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
The impact of study termination, the shorter observational periods and the resulting small sample size coupled with not having enough participants with post baseline assessments for various reasons were limiting factors for data interpretation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00667810     History of Changes
Obsolete Identifiers: NCT00909623
Other Study ID Numbers: 3133K1-3000
B2521001 ( Other Identifier: Alias Study Number )
2007-005994-79 ( EudraCT Number )
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: October 22, 2013
Results First Posted: January 8, 2016
Last Update Posted: January 8, 2016