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Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369225
First Posted: June 8, 2011
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
Results First Submitted: June 15, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: AAB-003 (PF-05236812)

  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 enrolled participants who completed the first-in-human (FIH) study, B2601001.

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
AAB-003 0.5 mg/kg Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 1 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 2 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 4 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 8 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
Placebo/AAB-003 Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.

Participant Flow:   Overall Study
    AAB-003 0.5 mg/kg   AAB-003 1 mg/kg   AAB-003 2 mg/kg   AAB-003 4 mg/kg   AAB-003 8 mg/kg   Placebo/AAB-003
STARTED   6   3   12   10   12   9 
COMPLETED   4   3   9   8   10   9 
NOT COMPLETED   2   0   3   2   2   0 
Withdrawal by Subject                1                0                2                1                0                0 
Does Not Meet Entrance Criteria                0                0                1                0                0                0 
Other                1                0                0                0                1                0 
Adverse Event                0                0                0                1                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 baseline analysis population included all participants who were enrolled in the study and received at least 1 infusion of study medication.

Reporting Groups
  Description
AAB-003 0.5 mg/kg Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 1 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 2 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 4 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
AAB-003 8 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
Placebo/AAB-003 Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
Total Total of all reporting groups

Baseline Measures
   AAB-003 0.5 mg/kg   AAB-003 1 mg/kg   AAB-003 2 mg/kg   AAB-003 4 mg/kg   AAB-003 8 mg/kg   Placebo/AAB-003   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   12   10   12   9   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (6.5)   63.0  (7.8)   68.8  (10.6)   71.3  (8.8)   60.7  (5.8)   71.7  (7.9)   67.1  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      4  66.7%      2  66.7%      10  83.3%      5  50.0%      8  66.7%      4  44.4%      33  63.5% 
Male      2  33.3%      1  33.3%      2  16.7%      5  50.0%      4  33.3%      5  55.6%      19  36.5% 


  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 Week 52 ]

2.  Primary:   Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern   [ Time Frame: Baseline up to Week 52 ]

3.  Primary:   Number of Participants With Potentially Clinically Important Vital Sign Findings   [ Time Frame: Baseline up to Week 52 ]

4.  Primary:   Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings   [ Time Frame: Baseline up to Week 52 ]

5.  Primary:   Number of Participants With Abnormal Physical Examination Findings   [ Time Frame: Baseline up to Week 52 ]

6.  Primary:   Number of Participants With Abnormal Neurological Examination Findings   [ Time Frame: Baseline up to Week 52 ]

7.  Primary:   Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Baseline up to Week 52 ]

8.  Primary:   Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings   [ Time Frame: Baseline up to Week 52 ]

9.  Other Pre-specified:   Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer   [ Time Frame: Baseline, Week 52 ]

10.  Other Pre-specified:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52   [ Time Frame: Baseline, Week 52 ]

11.  Other Pre-specified:   Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52   [ Time Frame: Baseline, Week 52 ]

12.  Other Pre-specified:   Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52   [ Time Frame: Baseline, Week 52 ]

13.  Other Pre-specified:   Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52   [ Time Frame: Baseline, Week 52 ]

14.  Other Pre-specified:   Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52   [ Time Frame: Baseline, Week 52 ]


  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
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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: NCT01369225     History of Changes
Other Study ID Numbers: B2601003
First Submitted: May 10, 2011
First Posted: June 8, 2011
Results First Submitted: June 15, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017