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Phase 3 IGIV, 10% in Alzheimer´s Disease

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ClinicalTrials.gov Identifier: NCT01524887
Recruitment Status : Terminated (The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.)
First Posted : February 2, 2012
Results First Posted : March 31, 2015
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer´s Disease
Interventions: Biological: Immune Globulin Intravenous (Human), 10% Solution
Biological: Human albumin 0.25%

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment was conducted at 58 clinical sites worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 508 enrolled subjects, 303 met entry criteria. 42 subjects discontinued before randomization due to study termination. Of 261 randomized subjects, 10 subjects discontinued before receiving treatment (7 study termination, 2 withdrawal by subject, 1 withdrawal by caregiver). Number of subjects who received treatment (IVIG,10% or placebo) = 251.

Reporting Groups
  Description
IGIV, 10% at High Dose (0.4 g/kg) Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
IGIV, 10% at Low Dose (0.2 g/kg) Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Placebo Control Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months

Participant Flow:   Overall Study
    IGIV, 10% at High Dose (0.4 g/kg)   IGIV, 10% at Low Dose (0.2 g/kg)   Placebo Control
STARTED   85   90   86 
Received Treatment   83   85   83 
COMPLETED   0 [1]   0 [1]   0 [1] 
NOT COMPLETED   85   90   86 
Withdrawal by Subject                6                2                3 
Adverse Event                5                1                1 
Protocol Violation                0                0                1 
Study termination                73                87                79 
Withdrawal by Caregiver                0                0                2 
Use of prohibited medication                1                0                0 
[1] No subject completed the study as Baxter Healthcare terminated the study early.



  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.
The baseline analysis population comprises treated subjects (=safety analysis set).

Reporting Groups
  Description
IGIV, 10% at High Dose (0.4 g/kg) Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
IGIV, 10% at Low Dose (0.2 g/kg) Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Placebo Control Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Total Total of all reporting groups

Baseline Measures
   IGIV, 10% at High Dose (0.4 g/kg)   IGIV, 10% at Low Dose (0.2 g/kg)   Placebo Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 83   85   83   251 
Age 
[Units: Years]
Mean (Standard Deviation) 		 72.0  (8.36)   69.9  (8.59)   70.6  (9.98)   70.8  (9.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      43  51.8%      37  43.5%      52  62.7%      132  52.6% 
Male      40  48.2%      48  56.5%      31  37.3%      119  47.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		       
American Indian or Alaska Native      0   0.0%      1   1.2%      0   0.0%      1   0.4% 
Asian      0   0.0%      1   1.2%      3   3.6%      4   1.6% 
Native Hawaiian or Other Pacific Islander      1   1.2%      0   0.0%      1   1.2%      2   0.8% 
Black or African American      1   1.2%      3   3.5%      1   1.2%      5   2.0% 
White      81  97.6%      79  92.9%      78  94.0%      238  94.8% 
More than one race      0   0.0%      1   1.2%      0   0.0%      1   0.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
 		       
United States   66   67   66   199 
Canada   8   7   7   22 
Spain   3   5   3   11 
Belgium   6   5   6   17 
Japan   0   1   1   2 


  Outcome Measures

1.  Primary:   Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 2

3.  Secondary:   ADCS-Clinical Global Impression of Change (CGIC) at 18 Months   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)   [ Time Frame: Baseline to 9 Months (actual time frame) ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study period: 18 Months ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Experiencing Any AEs and/or SAEs   [ Time Frame: Throughout the study period: 18 Months ]
  Show Outcome Measure 9

10.  Secondary:   Number of Infusions Temporally Associated With AEs and/or SAEs   [ Time Frame: During or within 72 hours of completion of an infusion ]
  Show Outcome Measure 10

11.  Secondary:   Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion   [ Time Frame: During or within 7 days of completion of an infusion ]
  Show Outcome Measure 11

12.  Secondary:   Number of Infusions Causally Associated With AEs and/or SAEs   [ Time Frame: Throughout the study period: 18 Months ]
  Show Outcome Measure 12

13.  Secondary:   Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE   [ Time Frame: Throughout infusions, approximately 2-5 hours ]
  Show Outcome Measure 13


  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
The primary and secondary outcome measures were originally planned to be assessed at 18 months. However, as the study was terminated early, an analysis was completed at 9 months instead, in a subset of subjects who had received 9 months of treatment.


  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: Kathy Tobias, MD, Global Medical Dir, Biotherapeutics, Neurology
Organization: Baxter Healthcare Corporation
e-mail: kathy_tobias@baxter.com



Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT01524887     History of Changes
Other Study ID Numbers: 161003
2011-000914-21 ( EudraCT Number )
First Submitted: January 20, 2012
First Posted: February 2, 2012
Results First Submitted: February 3, 2015
Results First Posted: March 31, 2015
Last Update Posted: November 24, 2017