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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab 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

Participant Flow:   Overall Study
    Placebo   Bapineuzumab
STARTED   441   658 
Treated   439   654 
COMPLETED   285   398 
NOT COMPLETED   156   260 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all randomized participants who received at least one infusion or portion of an infusion of study drug.

Reporting Groups
  Description
Placebo Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab 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 Total of all reporting groups

Baseline Measures
   Placebo   Bapineuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 439   654   1093 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.3  (7.75)   71.0  (7.67)   70.7  (7.71) 
Age, Customized 
[Units: Number of participants]
     
<65 years   97   132   229 
>=65 years   342   522   864 
Gender 
[Units: Number of participants]
     
Female   262   421   683 
Male   177   233   410 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

Measure Type Primary
Measure Title Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   300   414 
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78 
[Units: Unit on a scale]
Least Squares Mean (Standard Error)
 7.31  (0.47)   7.32  (0.39) 


Statistical Analysis 1 for Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.979
Mean Difference (Final Values) [5] 0.02
95% Confidence Interval -1.18 to 1.22
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

Measure Type Primary
Measure Title Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   301   411 
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78 
[Units: Unit on a scale]
Least Squares Mean (Standard Deviation)
 -14.94  (1.00)   -14.89  (0.84) 


Statistical Analysis 1 for Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.973
Mean Difference (Final Values) [5] 0.04
95% Confidence Interval -2.51 to 2.60
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Primary variable DAD total score had to reach statistical significance, p-values had to reach p <=0.05, in order to be declared effective.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change From Baseline in Brain Amyloid Burden at Week 71   [ Time Frame: Baseline and 71 weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Brain Amyloid Burden at Week 71
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   12   15 
Change From Baseline in Brain Amyloid Burden at Week 71 
[Units: Standard uptake value ratio]
Least Squares Mean (Standard Error)
 0.03  (0.04)   -0.04  (0.03) 


Statistical Analysis 1 for Change From Baseline in Brain Amyloid Burden at Week 71
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.159
Mean Difference (Final Values) [5] -0.07
95% Confidence Interval -0.17 to 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71   [ Time Frame: Baseline and 71 Weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   62   76 
Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71 
[Units: pg/mL]
Least Squares Mean (Standard Error)
 0.83  (2.04)   -0.55  (1.84) 


Statistical Analysis 1 for Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.620
Mean Difference (Final Values) [5] -1.38
95% Confidence Interval -6.89 to 4.13
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71   [ Time Frame: Baseline and 71 Weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   131   197 
Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71 
[Units: Milliliter (mL)/year]
Least Squares Mean (Standard Error)
 17.64  (0.69)   17.51  (0.56) 


Statistical Analysis 1 for Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.884
Mean Difference (Final Values) [5] -0.13
95% Confidence Interval -1.89 to 1.63
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



6.  Secondary:   Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

Measure Type Secondary
Measure Title Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 0.5 mg/kg 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

Measured Values
   Placebo   Bapineuzumab 0.5 mg/kg 
Participants Analyzed   431   650 
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78 
[Units: Units/Year]
Least Squares Mean (Standard Error)
   
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) 


Statistical Analysis 1 for Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.700
Mean Difference (Final Values) [5] 0.24
95% Confidence Interval -0.97 to 1.45
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment Difference: Bapineuzumab - Placebo
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



7.  Secondary:   Divergence of Effect on the DAD Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

Measure Type Secondary
Measure Title Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 0.5 mg/kg 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

Measured Values
   Placebo   Bapineuzumab 0.5 mg/kg 
Participants Analyzed   431   650 
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78 
[Units: Units/Year]
Least Squares Mean (Standard Error)
   
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) 


Statistical Analysis 1 for Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.949
Mean Difference (Final Values) [5] 0.09
95% Confidence Interval -2.61 to 2.78
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment Difference: Bapineuzumab - Placebo
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Secondary:   Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan) 
[Units: Days]
Median (95% Confidence Interval)
 463.0 
 (455.0 to 546.0) 
 457.0 
 (455.0 to 541.0) 


Statistical Analysis 1 for Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.684
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan) 
[Units: Days]
Median (95% Confidence Interval)
 NA [1] 
 (546.0 to N/A) 
 546.0 [1] 
 (546.0 to N/A) 
[1] Values were not calculable due to the large number of censored event times


Statistical Analysis 1 for Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.383
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan) 
[Units: Days]
Median (95% Confidence Interval)
 464.0 
 (455.0 to 546.0) 
 456.0 
 (449.0 to 539.0) 


Statistical Analysis 1 for Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.191
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis) 
[Units: Days]
Median (95% Confidence Interval)
 546.0 
 (542.0 to 546.0) 
 546.0 
 (540.0 to 546.0) 


Statistical Analysis 1 for Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.478
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Change From Baseline in Dependence Scale Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Dependence Scale Total Score at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   316   437 
Change From Baseline in Dependence Scale Total Score at Week 78 
[Units: Unit on a scale]
Least Squares Mean (Standard Error)
 1.33  (0.12)   1.22  (0.10) 


Statistical Analysis 1 for Change From Baseline in Dependence Scale Total Score at Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.462
Mean Difference (Final Values) [5] -0.11
95% Confidence Interval -0.41 to 0.13
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



13.  Secondary:   Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan) 
[Units: Percentage of participants]
Number (95% Confidence Interval)
   
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) 

No statistical analysis provided for Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)



14.  Secondary:   Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan) 
[Units: Percentage of participant]
 42.2   37.1 


Statistical Analysis 1 for Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.086
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



15.  Secondary:   Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan) 
[Units: Percentage of participants]
Number (95% Confidence Interval)
   
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) 

No statistical analysis provided for Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)



16.  Secondary:   Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)
Measure Description Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.
Time Frame Baseline and 78 Weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   431   650 
Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan) 
[Units: Percentage of participant]
 39.7   34.9 


Statistical Analysis 1 for Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.120
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Bapineuzumab 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

Measured Values
   Placebo   Bapineuzumab 
Participants Analyzed   310   427 
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 2.59  (0.16)   2.44  (0.13) 


Statistical Analysis 1 for Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.448
Mean Difference (Final Values) [5] -0.15
95% Confidence Interval -0.55 to 0.24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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