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A Long-Term Safety And Tolerability Extension Study 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:
NCT00998764
First received: October 16, 2009
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer Disease
Intervention: Drug: Bapineuzumab 0.5 mg/kg

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo/Bapineuzumab 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.
Bapineuzumab/Bapineuzumab 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.

Participant Flow:   Overall Study
    Placebo/Bapineuzumab   Bapineuzumab/Bapineuzumab
STARTED   216   276 
Treated   215   275 
COMPLETED   0   2 
NOT COMPLETED   216   274 
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 



  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.
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).

Reporting Groups
  Description
Placebo/Bapineuzumab 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.
Bapineuzumab/Bapineuzumab 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 Total of all reporting groups

Baseline Measures
   Placebo/Bapineuzumab   Bapineuzumab/Bapineuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 215   275   490 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.4  (8.14)   72.1  (7.47)   71.8  (7.77) 
Age, Customized 
[Units: Participants]
     
< 65 years   44   42   86 
>= 65 years   171   233   404 
Gender 
[Units: Participants]
     
Female   135   186   321 
Male   80   89   169 


  Outcome Measures
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1.  Primary:   Number of Participants Reporting a Serious Adverse Event   [ Time Frame: Up to Week 195 ]

2.  Secondary:   Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

3.  Secondary:   Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

4.  Secondary:   Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

5.  Secondary:   Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

6.  Secondary:   Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ]

7.  Secondary:   Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ]

8.  Secondary:   Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.   [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ]

9.  Secondary:   Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.   [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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: NCT00998764     History of Changes
Other Study ID Numbers: 3133K1-3003
B2521004 ( Other Identifier: Alias Study Number )
2009-015080-13 ( EudraCT Number )
Study First Received: October 16, 2009
Results First Received: October 15, 2013
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration