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A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

This study has been completed.
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00818662
First received: January 7, 2009
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer´s Disease
Interventions: Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg
Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg
Biological: Placebo solution: Human Albumin 0.25% - 4 mL/kg
Biological: Placebo solution: Human Albumin 0.25% - 2 mL/kg

  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
Recruitment was conducted in the U.S., and Canada, at 45 study sites. The first participant was enrolled in December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
702 participants were enrolled; 308 were screen failures; 4 were discontinued before randomization; and 7 were withdrawn after randomization, but prior to receiving investigational product. Therefore 383 participants were randomized.

Reporting Groups
  Description
IGIV, 10% 400mg/kg

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks

IGIV, 10% 200mg/kg

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks

Placebo 4 mL/kg

0.25% human albumin solution infused at 4 mL/kg/2weeks

Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks

Placebo 2 mL/kg

0.25% human albumin solution infused at 2 mL/kg/2weeks

Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks


Participant Flow:   Overall Study
    IGIV, 10% 400mg/kg     IGIV, 10% 200mg/kg     Placebo 4 mL/kg     Placebo 2 mL/kg  
STARTED     127     135     58     63  
COMPLETED     104     102     49     47  
NOT COMPLETED     23     33     9     16  
Adverse Event                 5                 14                 4                 3  
Withdrawal by Subject                 5                 4                 2                 2  
Death                 1                 3                 0                 0  
Physician Decision                 1                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 1  
Unwilling or Unable to Participate                 4                 6                 2                 4  
Protocol Violation                 1                 1                 0                 0  
Requires a Prohibited Medication                 1                 0                 0                 0  
Safety Risk                 1                 1                 0                 1  
Study Partner Unwilling or Unable                 3                 2                 1                 1  
Participant's health declined                 0                 0                 0                 1  
Caregiver to pursue other treatment                 0                 1                 0                 0  
Moving out of state                 0                 0                 0                 1  
Declined move to another study site                 1                 0                 0                 0  
Change in living situation                 0                 0                 0                 1  
Study partner decision                 0                 0                 0                 1  
Admitted to long term nursing care                 0                 1                 0                 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.
No text entered.

Reporting Groups
  Description
IGIV, 10% 400mg/kg

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks

IGIV, 10% 200mg/kg

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks

Placebo 4 mL/kg

0.25% human albumin solution infused at 4 mL/kg/2weeks

Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks

Placebo 2 mL/kg

0.25% human albumin solution infused at 2 mL/kg/2weeks

Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks

Total Total of all reporting groups

Baseline Measures
    IGIV, 10% 400mg/kg     IGIV, 10% 200mg/kg     Placebo 4 mL/kg     Placebo 2 mL/kg     Total  
Number of Participants  
[units: participants]
  127     135     58     63     383  
Age  
[units: years]
Mean ± Standard Deviation
  70.5  ± 9.6     70.1  ± 8.3     70.3  ± 9.7     70.1  ± 10.3     70.3  ± 9.3  
Gender  
[units: participants]
         
Female     69     74     33     33     209  
Male     58     61     25     30     174  
Region of Enrollment  
[units: participants]
         
United States     117     127     56     58     358  
Canada     10     8     2     5     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)   [ Time Frame: Baseline & 18 months ]

2.  Primary:   Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)   [ Time Frame: Baseline & 18 Months ]

3.  Secondary:   Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)   [ Time Frame: Baseline & 9 months ]

4.  Secondary:   Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)   [ Time Frame: Baseline & 9 Months ]

5.  Secondary:   Change From Baseline at 9 Months in Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment   [ Time Frame: Baseline & 9 Months ]

6.  Secondary:   Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment   [ Time Frame: Baseline & 18 Months ]

7.  Secondary:   Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination   [ Time Frame: Baseline & 18 months ]

8.  Secondary:   Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment   [ Time Frame: Baseline & 18 months ]

9.  Secondary:   Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response   [ Time Frame: Baseline & 18 months ]

10.  Secondary:   Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response   [ Time Frame: Baseline & 18 months ]

11.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward   [ Time Frame: Baseline & 18 months ]

12.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward   [ Time Frame: Baseline & 18 months ]

13.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency   [ Time Frame: Baseline & 18 months ]

14.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution   [ Time Frame: Baseline & 18 months ]

15.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency   [ Time Frame: Baseline & 18 months ]

16.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A   [ Time Frame: Baseline & 18 months ]

17.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B   [ Time Frame: Baseline & 18 months ]

18.  Secondary:   Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test   [ Time Frame: Baseline & 18 months ]

19.  Secondary:   Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class   [ Time Frame: Throughout the study period, approximately 4 years ]

20.  Secondary:   Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class   [ Time Frame: Throughout the study period, approximately 4 years ]

21.  Secondary:   Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class   [ Time Frame: Throughout the study period, approximately 4 years ]

22.  Secondary:   Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class   [ Time Frame: Throughout the study period, approximately 4 years ]

23.  Secondary:   Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)   [ Time Frame: During or within 72 hours of completion of an infusion ]

24.  Secondary:   Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study period, approximately 4 years ]

25.  Secondary:   Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)   [ Time Frame: Throughout each infusion period ]

26.  Secondary:   Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits   [ Time Frame: Throughout the study period, approximately 4 years ]

27.  Secondary:   Number of Participants Experiencing a Clinically Significant Rash   [ Time Frame: Throughout the study period, approximately 4 years ]


  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: David Gelmont, MD, Global Medical Director, Head of Specialty Products TA, BioTherapeutics
Organization: Baxter Healthcare Corporation
e-mail: david_gelmont@baxter.com


No publications provided


Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00818662     History of Changes
Other Study ID Numbers: 160701
Study First Received: January 7, 2009
Results First Received: June 27, 2014
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada