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

This study has been 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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00676143
First received: May 2, 2008
Last updated: May 3, 2016
Last verified: May 2016
History of Changes
Results First Received: October 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: bapineuzumab
Drug: placebo

  Participant Flow
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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
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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
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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  
Number of Participants  
[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
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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 ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]
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3.  Secondary:   Change From Baseline in Brain Amyloid Burden at Week 71   [ Time Frame: Baseline and 71 weeks ]
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4.  Secondary:   Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71   [ Time Frame: Baseline and 71 Weeks ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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

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

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

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 ]
  Show Outcome Measure 13

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

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 ]
  Show Outcome Measure 15

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

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 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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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 )
Study First Received: May 2, 2008
Results First Received: October 14, 2013
Last Updated: May 3, 2016
Health Authority: United States: Food and Drug Administration