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Trial record 5 of 31 for:    alzheimer dijon

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676143
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 : May 12, 2008
Results First Posted : June 10, 2016
Last Update Posted : June 10, 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 1100
Recruitment Details The study was conducted at 218 centers across the world. The study was terminated early by the sponsor on 06 August 2012. Enrollment had already been completed at the time of this decision. Participants who were still participating at that time were asked to complete an early withdrawal visit.
Pre-assignment Details  
Arm/Group Title Placebo Bapineuzumab
Hide Arm/Group Description Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks. Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Period Title: Overall Study
Started 441 658
Treated 439 654
Completed 285 398
Not Completed 156 260
Reason Not Completed
Adverse Event             34             60
Death             4             4
Lack of Efficacy             0             6
Lost to Follow-up             0             13
Physician Decision             5             8
Protocol Violation             4             8
Withdrawal by Subject             24             42
Discontinuation of study by sponsor             65             88
Failed to return             2             1
Loss of caregiver             5             3
Not specified             11             20
Participant participation unknown             1             4
Vasogenic edema recurrence             1             3
Arm/Group Title Placebo Bapineuzumab Total
Hide Arm/Group Description Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks. Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks Total of all reporting groups
Overall Number of Baseline Participants 439 654 1093
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 439 participants 654 participants 1093 participants
70.3  (7.75) 71.0  (7.67) 70.7  (7.71)
Age, Customized  
Measure Type: Number
Unit of measure:  Number of participants
Number Analyzed 439 participants 654 participants 1093 participants
<65 years 97 132 229
>=65 years 342 522 864
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 439 participants 654 participants 1093 participants
Female
262
  59.7%
421
  64.4%
683
  62.5%
Male
177
  40.3%
233
  35.6%
410
  37.5%
1.Primary Outcome
Title Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale 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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 300 414
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
7.31  (0.47) 7.32  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments

Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p <=0.05, in order to be declared effective.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-1.18 to 1.22
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Disability Assessment for Dementia (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 psychometric 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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 301 411
Least Squares Mean (Standard Deviation)
Unit of Measure: Unit on a scale
-14.94  (1.00) -14.89  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments

Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments Primary variable DAD total score had to reach statistical significance, p-values had to reach p <=0.05, in order to be declared effective.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-2.51 to 2.60
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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 semi-quantitative 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 Baseline and 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 postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.
Arm/Group Title Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 12 15
Least Squares Mean (Standard Error)
Unit of Measure: standard uptake value ratio
0.03  (0.04) -0.04  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments

Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.17 to 0.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71
Hide Description Biomarkers CSF phospho-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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 62 76
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
0.83  (2.04) -0.55  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.620
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-6.89 to 4.13
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71
Hide Description 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 Baseline and 71 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 131 197
Least Squares Mean (Standard Error)
Unit of Measure: Milliliter (mL)/year
17.64  (0.69) 17.51  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments

Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab 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.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-1.89 to 1.63
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 Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.
Time Frame Week 39 to Week 78
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 Placebo Bapineuzumab 0.5 mg/kg
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Least Squares Mean (Standard Error)
Unit of Measure: Units/Year
Week 39 2.95  (0.30) 2.68  (0.25)
Week 52 4.40  (0.34) 4.08  (0.29)
Week 65 5.76  (0.39) 5.16  (0.32)
Week 78 7.31  (0.47) 7.32  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab 0.5 mg/kg
Comments Treatment Difference: Bapineuzumab - Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.97 to 1.45
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Hide Description Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.
Time Frame Week 39 to Week 78
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 Placebo Bapineuzumab 0.5 mg/kg
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Least Squares Mean (Standard Error)
Unit of Measure: Units/Year
Week 39 -6.60  (0.65) -6.93  (0.54)
Week 52 -9.34  (0.73) -9.34  (0.61)
Week 65 -12.14  (0.91) -13.04  (0.76)
Week 78 -14.94  (1.00) -14.89  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab 0.5 mg/kg
Comments Treatment Difference: Bapineuzumab - Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-2.61 to 2.78
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Hide Description The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline 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 median time to first median placebo deterioration was presented.
Time Frame Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Median (95% Confidence Interval)
Unit of Measure: Days
463.0
(455.0 to 546.0)
457.0
(455.0 to 541.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
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 was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.
Time Frame Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(546.0 to NA)
546.0 [1] 
(546.0 to NA)
[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 Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
10.Secondary Outcome
Title Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)
Hide Description The time to first median placebo deterioration 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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Median (95% Confidence Interval)
Unit of Measure: Days
464.0
(455.0 to 546.0)
456.0
(449.0 to 539.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
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)
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 Baseline and 78 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Median (95% Confidence Interval)
Unit of Measure: Days
546.0
(542.0 to 546.0)
546.0
(540.0 to 546.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.478
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
12.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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 316 437
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.33  (0.12) 1.22  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.462
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.41 to 0.13
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)
Hide Description Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.
Time Frame Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Worsening of 0 points
18.3
(14.8 to 22.3)
15.5
(12.8 to 18.6)
Worsening of 3 points
30.4
(26.1 to 35.0)
25.5
(22.2 to 29.1)
Worsening of 7 points
42.5
(37.7 to 47.3)
38.0
(34.3 to 41.9)
14.Secondary Outcome
Title Percentage of Responders for 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 was <7.
Time Frame Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Measure Type: Number
Unit of Measure: Percentage of participant
42.2 37.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)
Hide Description Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.
Time Frame Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Worsening of 0 points
17.2
(13.7 to 21.1)
18.6
(15.7 to 21.8)
Worsening of 6 points
29.9
(25.6 to 34.5)
27.4
(24.0 to 31.0)
Worsening of 12 points
39.7
(35.0 to 44.5)
34.9
(31.3 to 38.7)
16.Secondary Outcome
Title Percentage of Responders for 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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 431 650
Measure Type: Number
Unit of Measure: Percentage of participant
39.7 34.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
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 Baseline and 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 Placebo Bapineuzumab
Hide Arm/Group Description:
Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Overall Number of Participants Analyzed 310 427
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.59  (0.16) 2.44  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bapineuzumab
Comments Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.55 to 0.24
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo Bapineuzumab
Hide Arm/Group Description Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks. Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
All-Cause Mortality
Placebo Bapineuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Bapineuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/439 (17.54%)      137/654 (20.95%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Bone marrow failure * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Leukocytosis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Angina pectoris * 1  2/439 (0.46%)  3 1/654 (0.15%)  1
Angina unstable * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Atrial fibrillation * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Atrioventricular block complete * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Atrioventricular block second degree * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Bradycardia * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Cardiac arrest * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Cardiovascular insufficiency * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Hypertensive heart disease * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Myocardial infarction * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Myocardial ischaemia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Sinus bradycardia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Supraventricular tachycardia * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Tachycardia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Eye disorders     
Cataract * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Vitreous haemorrhage * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Gastrointestinal disorders     
Abdominal pain * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Abdominal pain upper * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Anal haemorrhage * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Colonic polyp * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Diarrhoea * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Duodenal ulcer perforation * 1  0/439 (0.00%)  0 1/654 (0.15%)  3
Gastric ulcer * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Gastrointestinal ulcer haemorrhage * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Haematemesis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Ileus * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Inguinal hernia * 1  2/439 (0.46%)  2 0/654 (0.00%)  0
Inguinal hernia, obstructive * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Intestinal obstruction * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Nausea * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Oesophageal ulcer * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Pancreatitis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Pancreatitis acute * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Vomiting * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
General disorders     
Chest discomfort * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Chest pain * 1  1/439 (0.23%)  1 2/654 (0.31%)  2
Device occlusion * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Fibrosis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
General physical health deterioration * 1  0/439 (0.00%)  0 1/654 (0.15%)  2
Malaise * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Non-cardiac chest pain * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pain * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pyrexia * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Hepatobiliary disorders     
Bile duct stone * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Cholangitis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Cholecystitis * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Cholelithiasis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Gallbladder disorder * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Hepatic function abnormal * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Jaundice * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Immune system disorders     
Hypersensitivity * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Infections and infestations     
Abdominal abscess * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Abscess * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Appendicitis * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Bacterial Sepsis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Bronchitis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Cellulitis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Gastroenteritis * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Herpes zoster * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Infected skin ulcer * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Kidney infection * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Lower respiratory tract infection * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Meningitis cryptococcal * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Osteomyelitis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Paronychia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pneumonia * 1  3/439 (0.68%)  3 6/654 (0.92%)  6
Pseudomembranous colitis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pyelonephritis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Sepsis * 1  3/439 (0.68%)  4 1/654 (0.15%)  1
Toxic shock syndrome * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Urinary tract infection * 1  2/439 (0.46%)  2 2/654 (0.31%)  2
Urosepsis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Vaginitis bacterial * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Viral upper respiratory tract infection * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose * 1  1/439 (0.23%)  1 2/654 (0.31%)  3
Ankle fracture * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Contusion * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Drug administration error * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Excoriation * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Eye injury * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Fall * 1  1/439 (0.23%)  2 2/654 (0.31%)  2
Femoral neck fracture * 1  0/439 (0.00%)  0 2/654 (0.31%)  5
Femur fracture * 1  1/439 (0.23%)  1 3/654 (0.46%)  3
Head injury * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Hip fracture * 1  2/439 (0.46%)  5 1/654 (0.15%)  1
Humerus fracture * 1  0/439 (0.00%)  0 1/654 (0.15%)  3
Post lumbar puncture syndrome * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pubis fracture * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Radius fracture * 1  2/439 (0.46%)  3 0/654 (0.00%)  0
Rib fracture * 1  1/439 (0.23%)  3 0/654 (0.00%)  0
Spinal compression fracture * 1  2/439 (0.46%)  7 1/654 (0.15%)  1
Stab wound * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Subdural haematoma * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Upper limb fracture * 1  1/439 (0.23%)  2 0/654 (0.00%)  0
Wrist fracture * 1  2/439 (0.46%)  5 0/654 (0.00%)  0
Investigations     
Blood pressure increased * 1  1/439 (0.23%)  2 0/654 (0.00%)  0
Fibrin D dimer increased * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Heart rate increased * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Streptococcus test positive * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Metabolism and nutrition disorders     
Dehydration * 1  2/439 (0.46%)  2 3/654 (0.46%)  4
Hypoglycaemia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Hypokalaemia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Hyponatraemia * 1  0/439 (0.00%)  0 2/654 (0.31%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Arthritis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Back pain * 1  1/439 (0.23%)  1 2/654 (0.31%)  2
Intervertebral disc protrusion * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Lumbar spinal stenosis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Osteoarthritis * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Polymyalgia rheumatica * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Rhabdomyolysis * 1  2/439 (0.46%)  2 2/654 (0.31%)  2
Spinal column stenosis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Basal cell carcinoma * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Bladder cancer * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Breast cancer * 1  2/439 (0.46%)  2 2/654 (0.31%)  2
Breast neoplasm * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Hepatic neoplasm * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Leiomyosarcoma * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Lentigo maligna * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Metastatic neoplasm * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Neoplasm prostate * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Oesophageal carcinoma * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Prostate cancer * 1  4/439 (0.91%)  5 1/654 (0.15%)  1
Squamous cell carcinoma * 1  3/439 (0.68%)  3 0/654 (0.00%)  0
Nervous system disorders     
Amyotrophic lateral sclerosis * 1  0/439 (0.00%)  0 1/654 (0.15%)  5
Aphasia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Brain stem ischaemia * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Cerebral haemorrhage * 1  1/439 (0.23%)  1 3/654 (0.46%)  3
Cerebral haemosiderin deposition * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Cerebral infarction * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Cerebral ischaemia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Cerebral microhaemorrhage * 1  0/439 (0.00%)  0 4/654 (0.61%)  4
Cerebrovascular accident * 1  1/439 (0.23%)  2 0/654 (0.00%)  0
Convulsion * 1  0/439 (0.00%)  0 3/654 (0.46%)  3
Dizziness * 1  0/439 (0.00%)  0 1/654 (0.15%)  2
Epilepsy * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Grand mal convulsion * 1  1/439 (0.23%)  1 2/654 (0.31%)  2
Haemorrhagic stroke * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Hydrocephalus * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Ischaemic stroke * 1  0/439 (0.00%)  0 2/654 (0.31%)  3
Lacunar infarction * 1  1/439 (0.23%)  4 0/654 (0.00%)  0
Lethargy * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Loss of consciousness * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Mental impairment * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Paraesthesia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Presyncope * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Syncope * 1  2/439 (0.46%)  2 4/654 (0.61%)  4
Transient ischaemic attack * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Vasogenic cerebral oedema * 1  4/439 (0.91%)  5 40/654 (6.12%)  61
Visual field defect * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Agitation * 1  1/439 (0.23%)  3 2/654 (0.31%)  2
Psychiatric disorders     
Abnormal behaviour * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Aggression * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Completed suicide * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Confusional state * 1  2/439 (0.46%)  2 3/654 (0.46%)  3
Delirium * 1  1/439 (0.23%)  2 2/654 (0.31%)  2
Depression * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Hallucination * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Mental status changes * 1  2/439 (0.46%)  2 3/654 (0.46%)  3
Restlessness * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Suicide attempt * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Renal and urinary disorders     
Acute prerenal failure * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Haematuria * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Pollakiuria * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Renal failure acute * 1  1/439 (0.23%)  1 2/654 (0.31%)  2
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Breast mass * 1  1/439 (0.23%)  1 1/654 (0.15%)  1
Rectocele * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Paranasal cyst * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Pneumonia aspiration * 1  1/439 (0.23%)  2 1/654 (0.15%)  1
Pulmonary embolism * 1  2/439 (0.46%)  2 3/654 (0.46%)  3
Pulmonary oedema * 1  1/439 (0.23%)  1 3/654 (0.46%)  3
Respiratory failure * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Social circumstances     
Social problem * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Surgical and medical procedures     
Thyroidectomy * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Vascular disorders     
Arteriosclerosis * 1  1/439 (0.23%)  1 0/654 (0.00%)  0
Deep vein thrombosis * 1  1/439 (0.23%)  1 5/654 (0.76%)  5
Ischaemia * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
Peripheral artery stenosis * 1  0/439 (0.00%)  0 1/654 (0.15%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Bapineuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   198/439 (45.10%)      298/654 (45.57%)    
Gastrointestinal disorders     
Diarrhoea * 1  23/439 (5.24%)  30 34/654 (5.20%)  38
Infections and infestations     
Nasopharyngitis * 1  34/439 (7.74%)  40 45/654 (6.88%)  66
Urinary tract infection * 1  24/439 (5.47%)  37 30/654 (4.59%)  34
Injury, poisoning and procedural complications     
Fall * 1  27/439 (6.15%)  36 39/654 (5.96%)  47
Nervous system disorders     
Cerebral microhaemorrhage * 1  16/439 (3.64%)  38 76/654 (11.62%)  218
Dizziness * 1  23/439 (5.24%)  32 20/654 (3.06%)  26
Headache * 1  44/439 (10.02%)  98 45/654 (6.88%)  66
Vasogenic cerebral oedema * 1  5/439 (1.14%)  5 74/654 (11.31%)  123
Psychiatric disorders     
Anxiety * 1  26/439 (5.92%)  29 30/654 (4.59%)  61
Depression * 1  27/439 (6.15%)  73 35/654 (5.35%)  95
Vascular disorders     
Hypertension * 1  22/439 (5.01%)  50 18/654 (2.75%)  48
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
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: NCT00676143     History of Changes
Obsolete Identifiers: NCT00909675
Other Study ID Numbers: 3133K1-3001
B2521002 ( Other Identifier: Alias Study Number )
2007-005995-14 ( EudraCT Number )
First Submitted: May 2, 2008
First Posted: May 12, 2008
Results First Submitted: October 14, 2013
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016