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Trial record 28 of 31 for:    alzheimer dijon

A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

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ClinicalTrials.gov Identifier: NCT00996918
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 16, 2009
Results First Posted : January 1, 2014
Last Update Posted : January 1, 2014
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 0.5 mg/kg
Drug: Bapineuzumab 1.0 m/kg

  Participant Flow


  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.
No text entered.

Reporting Groups
  Description
Placebo/Bapineuzumab 0.5 mg/kg Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
Placebo/Bapineuzumab 1.0 mg/kg Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
Total Total of all reporting groups

Baseline Measures
   Placebo/Bapineuzumab 0.5 mg/kg   Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg   Placebo/Bapineuzumab 1.0 mg/kg   Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg   Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   62   33   53   4   190 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.9  (9.70)   71.9  (8.83)   68.8  (8.59)   70.6  (9.13)   71.3  (10.63)   70.4  (9.08) 
Age, Customized 
[Units: Number of participants]
           
< 65   17   15   12   17   1   62 
>= 65   21   47   21   36   3   128 
Gender 
[Units: Number of participants]
           
Female   13   28   14   19   3   77 
Male   25   34   19   34   1   113 


  Outcome Measures

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: 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: 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: Weeks 13, 26, 39, 52 and 78 ]

5.  Secondary:   Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78   [ Time Frame: 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: Weeks 26, 52 and 78 ]

7.  Secondary:   Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.   [ Time Frame: 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: 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: Weeks 6, 19, 32, 45 and 78 ]


  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
Bapineuzumab program was discontinued prematurely. Efficacy results obtained after Week 78 are not presented due to the very small number of participants after this time point.


  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: NCT00996918     History of Changes
Other Study ID Numbers: 3133K1-3002
B2521003
First Submitted: October 14, 2009
First Posted: October 16, 2009
Results First Submitted: November 12, 2013
Results First Posted: January 1, 2014
Last Update Posted: January 1, 2014