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Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

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:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
First received: June 4, 2009
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Alzheimer Disease
Intervention: Drug: bapineuzumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed the parent Study NCT00663026 and met the study criteria were enrolled and randomized into each of 3 dose cohorts to receive bapineuzumab or placebo. The study was terminated early on 06 August 2012 because 2 Phase 3 studies showed no clinical benefit. The decision was not based on any new safety concerns.

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
Bapineuzumab (5 mg + 5 mg) Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
Bapineuzumab (10 mg + 10 mg) Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
Placebo + Bapineuzumab 5mg Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
Placebo + Bapineuzumab 10 mg Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.

Participant Flow:   Overall Study
    Bapineuzumab (5 mg + 5 mg)   Bapineuzumab (10 mg + 10 mg)   Placebo + Bapineuzumab 5mg   Placebo + Bapineuzumab 10 mg
STARTED   24   21   10   7 
COMPLETED   1   0   0   0 
NOT COMPLETED   23   21   10   7 
Adverse Event                3                2                6                3 
Withdrawal by Subject                3                2                0                1 
Caregiver Request                3                2                1                0 
Physician Decision                1                1                0                0 
Discontinuation of Study by Sponsor                8                13                3                1 
Lost to Follow-up                2                1                0                0 
Lack of Efficacy                1                0                0                0 
Not specified                2                0                0                2 



  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.
All participants who received at least 1 dose of study medication in study NCT00916617 were included in the safety population.

Reporting Groups
  Description
Bapineuzumab (5 mg + 5 mg) Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
Bapineuzumab (10 mg + 10 mg) Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
Placebo + Bapineuzumab 5mg Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
Placebo + Bapineuzumab 10 mg Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
Total Total of all reporting groups

Baseline Measures
   Bapineuzumab (5 mg + 5 mg)   Bapineuzumab (10 mg + 10 mg)   Placebo + Bapineuzumab 5mg   Placebo + Bapineuzumab 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   21   10   7   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.2  (8.92)   74.0  (9.34)   80.4  (5.54)   70.3  (10.13)   73.9  (9.10) 
Age, Customized 
[Units: Participants]
         
Less than (<) 65 years   4   3   0   2   9 
Greater than or equal to (>=) 65 years   19   18   10   5   52 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      14  60.9%      8  38.1%      6  60.0%      2  28.6%      30  49.2% 
Male      9  39.1%      13  61.9%      4  40.0%      5  71.4%      31  50.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings   [ Time Frame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit ]

2.  Secondary:   Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination   [ Time Frame: 36 months ]


  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00916617     History of Changes
Other Study ID Numbers: 3133L1-2204
B2521009 ( Other Identifier: Alias Study Number )
Study First Received: June 4, 2009
Results First Received: September 25, 2013
Last Updated: April 27, 2017