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A Long-Term Safety And Tolerability Extension Study 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: NCT00998764
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 : October 20, 2009
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer Disease
Intervention Drug: Bapineuzumab 0.5 mg/kg
Enrollment 494
Recruitment Details This study was conducted at 147 centers in 19 countries. The study was terminated early by the sponsor on 06 August 2012. Subjects who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit.
Pre-assignment Details  
Arm/Group Title Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Hide Arm/Group Description Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195. Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Period Title: Overall Study
Started 216 276
Treated 215 275
Completed 0 2
Not Completed 216 274
Reason Not Completed
Lack of Efficacy             3             6
Adverse Event             17             12
Withdrawal by Subject             19             25
Physician Decision             3             3
Death             3             1
Discontinuation of Study by Sponsor             164             217
Protocol Violation             0             1
Failed to Return             1             1
Lost to Follow-up             1             1
Loss of Caregiver             0             3
Not specified             4             4
Recurrent Episode of vasogenic edema             1             0
Arm/Group Title Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab Total
Hide Arm/Group Description Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. Total of all reporting groups
Overall Number of Baseline Participants 215 275 490
Hide Baseline Analysis Population Description
The safety population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 275 participants 490 participants
71.4  (8.14) 72.1  (7.47) 71.8  (7.77)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 215 participants 275 participants 490 participants
< 65 years 44 42 86
>= 65 years 171 233 404
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 275 participants 490 participants
Female
135
  62.8%
186
  67.6%
321
  65.5%
Male
80
  37.2%
89
  32.4%
169
  34.5%
1.Primary Outcome
Title Number of Participants Reporting a Serious Adverse Event
Hide Description Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.
Time Frame Up to Week 195
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 215 275
Measure Type: Number
Unit of Measure: Number of Participants
35 33
2.Secondary Outcome
Title Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 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 Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 13 (N= 197, 253) 5.53  (0.57) 6.28  (0.50)
Week 26 (N = 154, 221) 7.41  (0.63) 7.70  (0.54)
Week 39 (N = 121, 184) 8.83  (0.72) 8.87  (0.61)
Week 52 (N = 91, 139) 10.12  (0.75) 10.11  (0.63)
Week 78 (N = 52, 80) 13.91  (0.96) 12.70  (0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
-0.74 to 2.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
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%
-1.33 to 1.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.966
Comments [Not Specified]
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%
-1.81 to 1.89
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-1.93 to 1.92
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-3.67 to 1.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 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 Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 13 (N = 197, 253) 0.89  (0.36) 0.73  (0.32)
Week 26 (N = 154, 221) 2.87  (0.42) 2.19  (0.35)
Week 39 (N = 121, 184) 4.26  (0.50) 3.35  (0.42)
Week 52 (N = 91, 139) 5.42  (0.55) 4.51  (0.45)
Week 78 (N = 52, 80) 9.21  (0.82) 7.07  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from extension study baseline in ADAS-Cog at week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
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%
-1.11 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from extension study baseline in ADAS-Cog at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.76 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from extension study baseline in ADAS-Cog at week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-2.19 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from extension study baseline in ADAS-Cog at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-2.30 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapineuzumab/Bapineuzumab
Comments Change from extension study baseline in ADAS-Cog at week 78
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.13
Confidence Interval (2-Sided) 95%
-4.21 to 0.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Hide Description The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 13 (N = 194, 247) -12.33  (1.27) 15.32  (1.11)
Week 26 (N = 151, 222) -15.37  (1.29) -18.04  (1.11)
Week 39 (N = 119, 180) -17.74  (1.47) -21.33  (1.24)
Week 52 (N = 89, 137) -20.96  (1.65) -22.72  (1.36)
Week 78 (N = 50, 81) -26.33  (2.18) -29.11  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in DAD score at Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.99
Confidence Interval (2-Sided) 95%
-6.30 to 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in DAD score at Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.67
Confidence Interval (2-Sided) 95%
-6.02 to 0.67
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in DAD score at Week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.60
Confidence Interval (2-Sided) 95%
-7.38 to 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in DAD score at Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-5.95 to 2.44
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in DAD score at Week 78
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.78
Confidence Interval (2-Sided) 95%
-8.28 to 2.73
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Hide Description The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on scale
Week 13 (N = 194, 247) -2.63  (0.83) -3.71  (0.73)
Week 26 (N = 151, 222) -5.76  (1.01) -6.46  (0.86)
Week 39 (N = 119, 180) -8.17  (1.22) -9.72  (1.02)
Week 52 (N = 89, 137) -11.82  (1.34) -11.11  (1.10)
Week 78 (N = 50, 81) -17.34  (1.94) -17.48  (1.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in DAD score at Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-3.24 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in DAD score at Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.601
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-3.31 to 1.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in DAD score at Week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-4.67 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in DAD score at Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.680
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
-2.70 to 4.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in DAD score at Week 78
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-5.05 to 4.77
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.
Hide Description NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 26, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 26 (N = 176, 240) 2.84  (0.97) 2.95  (0.83)
Week 52 (N = 110, 163) 4.32  (0.96) 3.52  (0.80)
Week 78 (N = 51, 81) 6.95  (1.70) 4.93  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in NPI score at week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
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%
-2.40 to 2.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in NPI score at week 52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.524
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-3.26 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in NPI score at week 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-6.32 to 2.27
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.
Hide Description NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 26, 52 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 26 (N = 176, 240) 2.17  (0.86) 1.47  (0.73)
Week 52 (N = 110, 163) 3.82  (0.95) 1.98  (0.79)
Week 78 (N = 51, 81) 6.60  (1.69) 3.29  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in NPI score at week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-2.92 to 1.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in NPI score at week 52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-4.28 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in NPI score at week 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.32
Confidence Interval (2-Sided) 95%
-7.60 to 0.96
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 6, 19, 32, 45 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 6 (N= 197, 255) -2.61  (0.22) -2.55  (0.19)
Week 19 (N = 184, 241) -3.13  (0.22) -3.01  (0.19)
Week 32 (N = 141, 204) -3.75  (0.24) -3.65  (0.20)
Week 45 (N = 117, 171) -4.44  (0.26) -4.26  (0.21)
Week 78 (N = 65, 94) -5.50  (0.32) -5.54  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in MMSE score at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
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%
-0.49 to 0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from base study baseline in MMSE score at Week 19.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.45 to 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 32.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.742
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.51 to 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 45.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.598
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%
-0.48 to 0.83
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
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%
-0.85 to 0.77
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.
Time Frame Base Study Baseline, Weeks 6, 19, 32, 45 and 78
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.
Arm/Group Title Placebo/Bapineuzumab Bapinezumab/Bapinezumab
Hide Arm/Group Description:
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Overall Number of Participants Analyzed 199 256
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 6 (N = 195, 255) -0.67  (0.19) -0.26  (0.16)
Week 19 (N = 182, 241) -1.16  (0.21) -0.69  (0.18)
Week 32 (N = 140, 204) -1.85  (0.24) -1.40  (0.20)
Week 45 (N = 116, 171) -2.57  (0.28) -2.05  (0.24)
Week 78 (N = 64, 94) -3.69  (0.39) -3.42  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.08 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 19.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
-0.07 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 32.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
-0.17 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 45.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.21 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo/Bapineuzumab, Bapinezumab/Bapinezumab
Comments Change from extension study baseline in MMSE score at Week 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.603
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
-0.73 to 1.26
Estimation Comments [Not Specified]
Time Frame 3 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 Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Hide Arm/Group Description Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
All-Cause Mortality
Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/215 (16.28%)      33/275 (12.00%)    
Cardiac disorders     
Aortic valve stenosis * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Atrial flutter * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Atrioventricular block * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Cardiac failure * 1  1/215 (0.47%)  1 1/275 (0.36%)  1
Cardiac failure congestive * 1  1/215 (0.47%)  1 1/275 (0.36%)  1
Cardiomyopathy * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Mitral valve disease * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Gastrointestinal haemorrhage * 1  2/215 (0.93%)  2 0/275 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Haemorrhoidal haemorrhage * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Haemorrhoids * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Pancreatitis * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
General disorders     
Asthenia * 1  0/215 (0.00%)  0 4/275 (1.45%)  4
Asthenia * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Chest pain * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Gait disturbance * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
General physical health deterioration * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Hepatobiliary disorders     
Cholelithiasis * 1  1/215 (0.47%)  2 0/275 (0.00%)  0
Hepatic steatosis * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Infections and infestations     
Bronchitis * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Gastritis viral * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Lower respiratory tract infection * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Peritonsillar abscess * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Pneumonia * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Urinary tract infection * 1  2/215 (0.93%)  2 1/275 (0.36%)  1
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Fall * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Femur fracture * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Forearm fracture * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Hip fracture * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Lower limb fracture * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Lumbar vertebral fracture * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Subdural haematoma * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Traumatic intracranial haemorrhage * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Wrist fracture * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Investigations     
Blood creatinine increased * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Muscular weakness * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Gastric cancer * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Metastases to lymph nodes * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Metastases to peritoneum * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Ovarian cancer * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Pancreatic carcinoma * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Squamous cell carcinoma of skin * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Nervous system disorders     
Carotid artery stenosis * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Cerebellar infarction * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Cerebral haemorrhage * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Cerebral infarction * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Cerebral microhaemorrhage * 1  2/215 (0.93%)  2 0/275 (0.00%)  0
Cerebrovascular accident * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Convulsion * 1  1/215 (0.47%)  1 2/275 (0.73%)  2
Epilepsy * 1  3/215 (1.40%)  3 0/275 (0.00%)  0
Ischaemic stroke * 1  1/215 (0.47%)  1 1/275 (0.36%)  1
Lacunar infarction * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Lumbar radiculopathy * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Multiple system atrophy * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Partial seizures * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Presyncope * 1  1/215 (0.47%)  1 0/275 (0.00%)  0
Subarachnoid haemorrhage * 1  2/215 (0.93%)  2 0/275 (0.00%)  0
Vasogenic cerebral oedema * 1  6/215 (2.79%)  6 2/275 (0.73%)  2
Psychiatric disorders     
Aggression * 1  1/215 (0.47%)  1 2/275 (0.73%)  2
Agitation * 1  1/215 (0.47%)  1 2/275 (0.73%)  2
Confusional state * 1  0/215 (0.00%)  0 2/275 (0.73%)  2
Delusion * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Hallucination * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Mental status changes * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Mood swings * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Suicidal ideation * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Renal and urinary disorders     
Incontinence * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
Vascular disorders     
Peripheral artery stenosis * 1  0/215 (0.00%)  0 1/275 (0.36%)  1
*
Indicates events were collected by non-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%
Placebo/Bapineuzumab Bapineuzumab/Bapineuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/215 (26.51%)      45/275 (16.36%)    
Gastrointestinal disorders     
Diarrhoea * 1  12/215 (5.58%)  12 10/275 (3.64%)  13
Nervous system disorders     
Cerebral microhaemorrhage * 1  18/215 (8.37%)  22 15/275 (5.45%)  16
Headache * 1  16/215 (7.44%)  29 8/275 (2.91%)  8
Vasogenic cerebral oedema * 1  17/215 (7.91%)  24 8/275 (2.91%)  8
Psychiatric disorders     
Anxiety * 1  11/215 (5.12%)  13 7/275 (2.55%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998764     History of Changes
Other Study ID Numbers: 3133K1-3003
B2521004 ( Other Identifier: Alias Study Number )
2009-015080-13 ( EudraCT Number )
First Submitted: October 16, 2009
First Posted: October 20, 2009
Results First Submitted: October 15, 2013
Results First Posted: January 1, 2016
Last Update Posted: January 1, 2016