Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00663026
First received: April 17, 2008
Last updated: September 11, 2013
Last verified: September 2013
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: bapineuzumab
Drug: placebo

  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
No text entered.

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 Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
Bapineuzumab 5 mg Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.

Participant Flow:   Overall Study
    Placebo     Bapineuzumab 5 mg     Bapineuzumab 10 mg  
STARTED     19     29     31  
COMPLETED     17     23     27  
NOT COMPLETED     2     6     4  
Lost to Follow-up                 1                 0                 0  
Unspecified                 1                 2                 0  
Adverse Event                 0                 2                 3  
Caregiver Request                 0                 2                 0  
Withdrawal by Subject                 0                 0                 1  



  Baseline Characteristics
  Hide 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 Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
Bapineuzumab 5 mg Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Total Total of all reporting groups

Baseline Measures
    Placebo     Bapineuzumab 5 mg     Bapineuzumab 10 mg     Total  
Number of Participants  
[units: participants]
  19     29     31     79  
Age  
[units: years]
Mean ± Standard Deviation
  76.16  ± 8.63     71.28  ± 8.73     72.42  ± 8.83     72.90  ± 8.85  
Gender  
[units: participants]
       
Female     8     18     12     38  
Male     11     11     19     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 30 days after Week 25 dose ]

2.  Secondary:   Maximum Observed Serum Concentration (Cmax)   [ Time Frame: Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]

3.  Secondary:   Average Serum Concentration at Steady State (Cavg,ss)   [ Time Frame: Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]

4.  Secondary:   Serum Decay Half-Life (t1/2)   [ Time Frame: Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]

5.  Secondary:   Time to Reach Maximum Observed Serum Concentration (Tmax)   [ Time Frame: Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]

6.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)   [ Time Frame: Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]

7.  Secondary:   Apparent Systemic Clearance (CL/F)   [ Time Frame: Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Designation of outcomes as primary, secondary was based on study team’s input as study did not specify them as primary or secondary.


  More Information
  Hide 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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663026     History of Changes
Other Study ID Numbers: 3133L1-2203, B2521008
Study First Received: April 17, 2008
Results First Received: September 11, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration