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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

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.
ClinicalTrials.gov Identifier: NCT00818662
Recruitment Status : Completed
First Posted : January 8, 2009
Results First Posted : October 28, 2014
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
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% (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
Enrollment 390
Recruitment Details Recruitment was conducted in the U.S., and Canada, at 45 study sites. The first participant was enrolled in December 2008.
Pre-assignment Details 702 participants were enrolled; 308 were screen failures; 4 were discontinued before randomization; and 7 were withdrawn after randomization, but prior to receiving investigational product.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.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 4 mL/kg Placebo 2 mL/kg
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Overall Study
Started 127 135 58 63
Completed 104 102 49 47
Not Completed 23 33 9 16
Reason Not Completed
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
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 4 mL/kg Placebo 2 mL/kg Total
Hide Arm/Group Description

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

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 127 135 58 63 383
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 135 participants 58 participants 63 participants 383 participants
70.5  (9.6) 70.1  (8.3) 70.3  (9.7) 70.1  (10.3) 70.3  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 135 participants 58 participants 63 participants 383 participants
Female
69
  54.3%
74
  54.8%
33
  56.9%
33
  52.4%
209
  54.6%
Male
58
  45.7%
61
  45.2%
25
  43.1%
30
  47.6%
174
  45.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 135 participants 58 participants 63 participants 383 participants
United States 117 127 56 58 358
Canada 10 8 2 5 25
1.Primary Outcome
Title Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Hide Description

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.

Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 105 100 95
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
7.4  (7.95) 8.9  (8.20) 8.4  (9.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.8
Confidence Interval 95%
-3.1 to 1.5
Estimation Comments Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.530
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.7
Confidence Interval 95%
-1.6 to 3.0
Estimation Comments Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level
2.Primary Outcome
Title Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Hide Description

The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.

Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.

Time Frame Baseline & 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 104 102 95
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-11.4  (10.49) -12.4  (11.41) -11.4  (12.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.812
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.4
Confidence Interval 95%
-2.9 to 3.7
Estimation Comments Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.9
Confidence Interval 95%
-4.3 to 2.5
Estimation Comments Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level
3.Secondary Outcome
Title Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Hide Description

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.

Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Time Frame Baseline & 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 114 114 106
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.7  (5.20) 4.5  (6.16) 3.5  (6.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.7
Confidence Interval 95%
-2.3 to 0.8
Estimation Comments Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.8
Confidence Interval 95%
-0.8 to 2.4
Estimation Comments Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)
4.Secondary Outcome
Title Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Hide Description

The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.

Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.

Time Frame Baseline & 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 111 116 107
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-5.4  (7.03) -6.1  (8.13) -5.8  (8.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.3
Confidence Interval 95%
-1.8 to 2.4
Estimation Comments Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.851
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.2
Confidence Interval 95%
-2.3 to 1.9
Estimation Comments Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)
5.Secondary Outcome
Title Change From Baseline at 9 Months in Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment
Hide Description

The ADCS-CGIC is a validated categorical measure of change in a participant’s clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.

A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).

  1. Very much better
  2. Much better
  3. A little better
  4. Same
  5. A little worse
  6. Much worse
  7. Very much worse
Time Frame Baseline & 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 114 114 104
Measure Type: Number
Unit of Measure: participants
Month 9: Very much better (1) 0 0 0
Month 9: Much better (2) 2 1 1
Month 9: A little better (3) 7 3 7
Month 9: Same (4) 33 33 36
Month 9: A little worse (5) 52 56 48
Month 9: Much worse (6) 19 18 12
Month 9: Very much worse (7) 1 3 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.1
Confidence Interval 95%
-0.1 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.3
Confidence Interval 95%
0.0 to 0.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment
Hide Description

The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.

A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).

  1. Very much better
  2. Much better
  3. A little better
  4. Same
  5. A little worse
  6. Much worse
  7. Very much worse
Time Frame Baseline & 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 105 101 92
Measure Type: Number
Unit of Measure: participants
Month 18: Very much better (1) 0 0 0
Month 18: Much better (2) 1 2 1
Month 18: A little better (3) 6 1 3
Month 18: Same (4) 15 15 16
Month 18: A little worse (5) 44 43 36
Month 18: Much worse (6) 32 33 32
Month 18: Very much worse (7) 7 7 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.1
Confidence Interval 95%
-0.3 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.0
Confidence Interval 95%
-0.2 to 0.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination
Hide Description The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 103 102 91
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-12.1  (13.12) -15.3  (12.76) -13.5  (10.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 1.9
Confidence Interval 95%
-1.0 to 4.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.4
Confidence Interval 95%
-4.3 to 1.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment
Hide Description The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 104 102 94
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.7  (12.93) 4.9  (13.30) 2.4  (10.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.7
Confidence Interval 95%
-2.1 to 3.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 2.5
Confidence Interval 95%
-0.3 to 5.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response
Hide Description The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 99 99 86
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (5.34) -0.7  (4.40) -1.5  (5.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 1.1
Confidence Interval 95%
-0.2 to 2.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 1.1
Confidence Interval 95%
-0.2 to 2.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response
Hide Description The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 99 99 92
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.0  (4.97) -2.5  (5.17) -1.6  (5.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, IGIV, 10% 200mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.1
Confidence Interval 95%
-2.3 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.0
Confidence Interval 95%
-2.2 to 0.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward
Hide Description This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 97 93 88
Mean (Standard Deviation)
Unit of Measure: correct responses
-0.8  (2.00) -1.2  (2.21) -1.1  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.4
Confidence Interval 95%
-0.2 to 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.998
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.0
Confidence Interval 95%
-0.6 to 0.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward
Hide Description This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 94 89 86
Mean (Standard Deviation)
Unit of Measure: correct responses
-0.8  (1.95) -1.2  (1.88) -1.2  (1.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.4
Confidence Interval 95%
-0.2 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.1
Confidence Interval 95%
-0.4 to 0.6
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency
Hide Description In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as ‘acts,’ ‘acted,’ ‘acting’). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 96 91 85
Mean (Standard Deviation)
Unit of Measure: correct responses
-4.7  (8.60) -7.4  (9.00) -6.3  (8.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 1.5
Confidence Interval 95%
-1.0 to 4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.400
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.1
Confidence Interval 95%
-3.6 to 1.4
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution
Hide Description WAIS–R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a ‘key,’ which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 80 63 67
Mean (Standard Deviation)
Unit of Measure: correct responses
-6.8  (10.61) -7.7  (9.67) -6.2  (7.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.695
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.6
Confidence Interval 95%
-3.6 to 2.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.410
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.3
Confidence Interval 95%
-4.5 to 1.9
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency
Hide Description In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category “animals” as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 97 92 87
Mean (Standard Deviation)
Unit of Measure: correct responses
-2.8  (4.06) -2.2  (6.84) -2.7  (3.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.988
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.0
Confidence Interval 95%
-1.5 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.555
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value 0.4
Confidence Interval 95%
-1.0 to 1.9
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A
Hide Description This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 83 75 74
Mean (Standard Deviation)
Unit of Measure: seconds
21.6  (36.93) 20.5  (30.61) 21.3  (35.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.5
Confidence Interval 95%
-12.2 to 9.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -2.1
Confidence Interval 95%
-13.1 to 8.8
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B
Hide Description This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 61 51 50
Mean (Standard Deviation)
Unit of Measure: seconds
13.0  (60.49) 28.4  (65.01) 31.9  (66.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -15.2
Confidence Interval 95%
-38.0 to 7.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.892
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -1.6
Confidence Interval 95%
-25.4 to 22.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test
Hide Description In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to ‘ten after eleven.’ Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).
Time Frame Baseline & 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set with both baseline and month 18 assessments.
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

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

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

All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Overall Number of Participants Analyzed 94 90 85
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (1.27) -0.7  (1.15) -0.6  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 400mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.1
Confidence Interval 95%
-0.4 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% 200mg/kg, Placebo 2 mL/kg or 4 mL/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-square means
Estimated Value -0.2
Confidence Interval 95%
-0.5 to 0.2
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class
Hide Description [Not Specified]
Time Frame Throughout the study period, approximately 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
Blood and Lymphatic System Disorders 7 2 1
Cardiac Disorders 1 0 4
Eye Disorders 1 1 0
Gastrointestinal Disorders 10 13 7
General Disorders & Administration Site Conditions 22 32 13
Immune System Disorders 0 1 0
Infections and Infestations 1 1 1
Injury, Poisoning, and Procedural Complications 5 1 0
Investigations 15 16 13
Metabolism and Nutrition Disorders 0 1 0
Musculoskeletal and Connective Tissue Disorders 7 5 0
Nervous System Disorders 33 34 24
Psychiatric Disorders 5 6 2
Reproductive System and Breast Disorders 0 1 0
Respiratory, Thoracic and Mediastinal Disorders 3 4 4
Skin and Subcutaneous Tissue Disorders 26 20 9
Vascular Disorders 10 18 17
20.Secondary Outcome
Title Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class
Hide Description [Not Specified]
Time Frame Throughout the study period, approximately 4 years
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Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
Cardiac Disorders 1 0 1
General Disorders & Administration Site Conditions 0 0 1
Immune System Disorders 0 1 0
Investigations 0 2 0
Nervous System Disorders 1 2 0
Psychiatric Disorders 0 1 0
Respiratory, Thoracic and Mediastinal Disorders 0 1 1
Vascular Disorders 0 0 2
21.Secondary Outcome
Title Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class
Hide Description Related and unrelated non-SAEs
Time Frame Throughout the study period, approximately 4 years
Show Outcome Measure DataHide Outcome Measure Data
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Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
Blood and Lymphatic System Disorders 13 7 5
Cardiac Disorders 3 11 15
Ear and Labyrinth Disorders 4 3 5
Endocrine Disorders 1 0 1
Eye Disorders 14 5 9
Gastrointestinal Disorders 47 51 36
General Disorders & Administration Site Conditions 57 66 52
Immune System Disorders 1 7 3
Infections and Infestations 40 46 57
Injury, Poisoning, and Procedural Complications 36 37 50
Investigations 37 48 30
Metabolism and Nutrition Disorders 14 15 16
Musculoskeletal and Connective Tissue Disorders 40 44 27
Neoplasms, Benign, Malignant and Unspecified 8 8 13
Nervous System Disorders 63 73 53
Psychiatric Disorders 41 49 49
Renal and Urinary Disorders 13 16 12
Reproductive System and Breast Disorders 5 4 3
Respiratory, Thoracic and Mediastinal Disorders 23 35 23
Skin and Subcutaneous Tissue Disorders 49 52 31
Social Circumstances 0 1 0
Surgical and Medical Procedures 8 6 8
Vascular Disorders 22 30 31
22.Secondary Outcome
Title Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class
Hide Description Related and unrelated SAEs
Time Frame Throughout the study period, approximately 4 years
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Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
Blood and Lymphatic System Disorders 2 0 1
Cardiac Disorders 5 3 3
Ear and Labyrinth Disorders 1 0 0
Gastrointestinal Disorders 5 1 1
General Disorders & Administration Site Conditions 2 4 2
Hepatobiliary Disorders 0 1 1
Immune System Disorders 0 1 0
Infections and Infestations 2 2 4
Injury, Poisoning, and Procedural Complications 3 2 2
Investigations 1 2 1
Metabolism and Nutrition Disorders 1 1 2
Musculoskeletal and Connective Tissue Disorders 2 3 0
Neoplasms, Benign, Malignant and Unspecified 0 3 3
Nervous System Disorders 3 6 5
Psychiatric Disorders 2 4 3
Renal and Urinary Disorders 0 1 1
Respiratory, Thoracic and Mediastinal Disorders 1 2 3
Surgical and Medical Procedures 0 1 1
Vascular Disorders 4 0 4
23.Secondary Outcome
Title Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)
Hide Description Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)
Time Frame During or within 72 hours of completion of an infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
3883 3954 3691
Measure Type: Number
Unit of Measure: Infusions
396 467 349
24.Secondary Outcome
Title Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)
Hide Description Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered
Time Frame Throughout the study period, approximately 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
3883 3954 3691
Measure Type: Number
Unit of Measure: Infusions
225 265 172
25.Secondary Outcome
Title Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)
Hide Description [Not Specified]
Time Frame Throughout each infusion period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
3883 3954 3691
Measure Type: Number
Unit of Measure: Adverse events
48 28 36
26.Secondary Outcome
Title Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits
Hide Description [Not Specified]
Time Frame Throughout the study period, approximately 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
31 24 16
27.Secondary Outcome
Title Number of Participants Experiencing a Clinically Significant Rash
Hide Description Participants requiring systemic therapy or discontinuation from further treatment
Time Frame Throughout the study period, approximately 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description:

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

Overall Number of Participants Analyzed 127 135 121
Measure Type: Number
Unit of Measure: participants
Rash requiring discontinuation from treatment 3 2 0
Rash requiring systemic therapy 19 16 8
Time Frame Throughout the study period of approximately 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Hide Arm/Group Description

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

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

Adverse Events That Occurred During or After Treatment

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

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

Adverse Events That Occurred During or After Treatment

All participants who received the 2 mL/kg or 4 mL/kg placebo solution

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

Adverse Events That Occurred During or After Treatment

All-Cause Mortality
IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/127 (16.54%)      32/135 (23.70%)      26/121 (21.49%)    
Blood and lymphatic system disorders       
Anaemia  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Microcytic Anaemia  2/127 (1.57%)  2 0/135 (0.00%)  0 0/121 (0.00%)  0
Cardiac disorders       
Arrhythmia  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Atrial Fibrillation  1/127 (0.79%)  1 1/135 (0.74%)  1 1/121 (0.83%)  2
Bundle Branch Block Left  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Cardiac Failure Congestive  1/127 (0.79%)  2 0/135 (0.00%)  0 1/121 (0.83%)  1
Coronary Artery Disease  2/127 (1.57%)  2 0/135 (0.00%)  0 0/121 (0.00%)  0
Myocardial Infarction  1/127 (0.79%)  1 0/135 (0.00%)  0 1/121 (0.83%)  1
Sinus Bradycardia  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Ear and labyrinth disorders       
Sudden Hearing Loss  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Gastrointestinal disorders       
Colitis  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Diaphragmatic Hernia, Obstructive  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Ileus  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Inguinal Hernia  0/127 (0.00%)  0 1/135 (0.74%)  2 0/121 (0.00%)  0
Small Intestinal Obstruction  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Upper Gastrointestinal Haemorrhage  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Vomiting  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
General disorders       
Asthenia  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Chest Pain  0/127 (0.00%)  0 2/135 (1.48%)  3 0/121 (0.00%)  0
Multi-Organ Failure  0/127 (0.00%)  0 2/135 (1.48%)  2 0/121 (0.00%)  0
Non-Cardiac Chest Pain  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Pyrexia  0/127 (0.00%)  0 0/135 (0.00%)  0 2/121 (1.65%)  2
Hepatobiliary disorders       
Cholecystitis Chronic  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Cholelithiasis  0/127 (0.00%)  0 1/135 (0.74%)  1 1/121 (0.83%)  1
Immune system disorders       
Anaphylactic Reaction  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Infections and infestations       
Gallbladder Abscess  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Gastroenteritis  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Gastroenteritis Viral  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Joint Abscess  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Pneumonia  1/127 (0.79%)  1 0/135 (0.00%)  0 1/121 (0.83%)  1
Urinary Tract Infection  1/127 (0.79%)  1 1/135 (0.74%)  1 3/121 (2.48%)  3
Injury, poisoning and procedural complications       
Ankle Fracture  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Muscle Rupture  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Pneumothorax Traumatic  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Spinal Fracture  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Subdural Haematoma  2/127 (1.57%)  2 0/135 (0.00%)  0 0/121 (0.00%)  0
Upper Limb Fracture  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Investigations       
Blood Pressure Increased  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Electrocardiogram Abnormal  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Haemoglobin Decreased  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Weight Decreased  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Metabolism and nutrition disorders       
Dehydration  1/127 (0.79%)  1 0/135 (0.00%)  0 2/121 (1.65%)  2
Hypokalaemia  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Intervertebral Disc Compression  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Musculoskeletal Chest Pain  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Musculoskeletal Pain  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Osteoarthritis  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-Cell Lymphoma  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Breast Cancer  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Colon Cancer Metastatic  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Lung Neoplasm Malignant  0/127 (0.00%)  0 1/135 (0.74%)  1 2/121 (1.65%)  2
Nervous system disorders       
Cerebral Haemorrhage  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Headache  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Normal Pressure Hydrocephalus  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Partial Seizures  1/127 (0.79%)  1 1/135 (0.74%)  1 0/121 (0.00%)  0
Radicular Pain  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Syncope  0/127 (0.00%)  0 3/135 (2.22%)  3 2/121 (1.65%)  3
Transient Ischaemic Attack  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Unresponsive To Stimuli  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Vasogenic Cerebral Oedema  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Psychiatric disorders       
Agitation  1/127 (0.79%)  1 0/135 (0.00%)  0 2/121 (1.65%)  2
Confusional State  1/127 (0.79%)  1 1/135 (0.74%)  1 0/121 (0.00%)  0
Mental Status Changes  0/127 (0.00%)  0 1/135 (0.74%)  1 1/121 (0.83%)  1
Psychotic Disorder  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Psychotic Disorder Due To A General Medical Condition  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Renal and urinary disorders       
Calculus Ureteric  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Renal Failure Acute  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Pneumothorax  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Pulmonary Embolism  1/127 (0.79%)  1 1/135 (0.74%)  1 2/121 (1.65%)  2
Surgical and medical procedures       
Inguinal Hernia Repair  0/127 (0.00%)  0 0/135 (0.00%)  0 1/121 (0.83%)  1
Knee Arthroplasty  0/127 (0.00%)  0 1/135 (0.74%)  1 0/121 (0.00%)  0
Vascular disorders       
Aortic Stenosis * 1  1/127 (0.79%)  1 0/135 (0.00%)  0 0/121 (0.00%)  0
Deep Vein Thrombosis  1/127 (0.79%)  1 0/135 (0.00%)  0 3/121 (2.48%)  3
Orthostatic Hypotension  2/127 (1.57%)  2 0/135 (0.00%)  0 1/121 (0.83%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IGIV, 10% 400mg/kg IGIV, 10% 200mg/kg Placebo 2 mL/kg or 4 mL/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/127 (88.19%)      118/135 (87.41%)      103/121 (85.12%)    
Blood and lymphatic system disorders       
Anaemia  7/127 (5.51%)  9 3/135 (2.22%)  3 2/121 (1.65%)  2
Cardiac disorders       
Bradycardia  1/127 (0.79%)  1 4/135 (2.96%)  4 8/121 (6.61%)  9
Gastrointestinal disorders       
Diarrhoea  18/127 (14.17%)  23 19/135 (14.07%)  24 15/121 (12.40%)  16
Nausea  16/127 (12.60%)  24 11/135 (8.15%)  23 10/121 (8.26%)  16
Vomiting  12/127 (9.45%)  16 6/135 (4.44%)  10 5/121 (4.13%)  6
General disorders       
Chills  10/127 (7.87%)  12 15/135 (11.11%)  33 3/121 (2.48%)  3
Fatigue  10/127 (7.87%)  11 13/135 (9.63%)  35 12/121 (9.92%)  28
Gait Disturbance  2/127 (1.57%)  2 10/135 (7.41%)  12 3/121 (2.48%)  3
Infusion Site Extravasation  23/127 (18.11%)  32 15/135 (11.11%)  18 21/121 (17.36%)  30
Oedema Peripheral  5/127 (3.94%)  5 7/135 (5.19%)  9 6/121 (4.96%)  7
Pyrexia  7/127 (5.51%)  8 7/135 (5.19%)  15 4/121 (3.31%)  4
Infections and infestations       
Nasopharyngitis  6/127 (4.72%)  6 10/135 (7.41%)  10 9/121 (7.44%)  13
Upper Respiratory Tract Infection  8/127 (6.30%)  9 8/135 (5.93%)  9 10/121 (8.26%)  11
Urinary Tract Infection  12/127 (9.45%)  16 8/135 (5.93%)  10 15/121 (12.40%)  21
Injury, poisoning and procedural complications       
Contusion  9/127 (7.09%)  9 13/135 (9.63%)  17 10/121 (8.26%)  20
Fall  14/127 (11.02%)  20 16/135 (11.85%)  20 23/121 (19.01%)  31
Laceration  7/127 (5.51%)  9 5/135 (3.70%)  5 9/121 (7.44%)  10
Investigations       
Blood Pressure Increased  19/127 (14.96%)  65 12/135 (8.89%)  67 9/121 (7.44%)  49
Weight Decreased  2/127 (1.57%)  2 7/135 (5.19%)  8 2/121 (1.65%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  12/127 (9.45%)  12 7/135 (5.19%)  7 4/121 (3.31%)  4
Back Pain  12/127 (9.45%)  13 11/135 (8.15%)  13 8/121 (6.61%)  8
Pain In Extremity  8/127 (6.30%)  11 4/135 (2.96%)  6 5/121 (4.13%)  5
Nervous system disorders       
Cerebral Microhaemorrhage  8/127 (6.30%)  9 1/135 (0.74%)  1 4/121 (3.31%)  5
Dizziness  16/127 (12.60%)  23 13/135 (9.63%)  16 12/121 (9.92%)  15
Headache  29/127 (22.83%)  114 34/135 (25.19%)  101 22/121 (18.18%)  65
Tremor  1/127 (0.79%)  1 12/135 (8.89%)  13 5/121 (4.13%)  5
Psychiatric disorders       
Agitation  9/127 (7.09%)  9 10/135 (7.41%)  10 10/121 (8.26%)  12
Anxiety  9/127 (7.09%)  12 14/135 (10.37%)  16 10/121 (8.26%)  15
Confusional State  5/127 (3.94%)  5 13/135 (9.63%)  19 4/121 (3.31%)  6
Depression  14/127 (11.02%)  14 16/135 (11.85%)  18 19/121 (15.70%)  22
Insomnia  1/127 (0.79%)  1 9/135 (6.67%)  10 9/121 (7.44%)  11
Respiratory, thoracic and mediastinal disorders       
Cough  8/127 (6.30%)  8 13/135 (9.63%)  19 13/121 (10.74%)  13
Epistaxis  12/127 (9.45%)  15 3/135 (2.22%)  3 3/121 (2.48%)  5
Skin and subcutaneous tissue disorders       
Eczema  7/127 (5.51%)  9 3/135 (2.22%)  4 1/121 (0.83%)  1
Rash  21/127 (16.54%)  27 19/135 (14.07%)  27 6/121 (4.96%)  10
Vascular disorders       
Hypertension  14/127 (11.02%)  27 18/135 (13.33%)  27 11/121 (9.09%)  22
Hypotension  3/127 (2.36%)  3 6/135 (4.44%)  7 7/121 (5.79%)  9
1
Term from vocabulary, MedDRA (Unspecified)
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.
Agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication (by USCD) or 12 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥45 days prior to submission or communication. Baxter may request an additional delay of ≤45 days(e.g., for intellectual property protection)
Results Point of Contact
Name/Title: David Gelmont, MD, Global Medical Director, Head of Specialty Products TA, BioTherapeutics
Organization: Baxter Healthcare Corporation
Publications:
Relkin N, Gessert D, Stokes K, Adamiak B, Ngo LY, Thomas R, Gelmont D, Aisen P. The Gammaglobulin Alzheimer Partnership Study (GAP): Design, screening, enrollment and futility analysis results. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 8[4 Suppl], P456. 2012.
Ngo L, Adamiak B, Gelmont D. A confirmatory phase 3 randomized, double-blind, placebo-controlled study of the safety and effectiveness of immune globulin intravenous (human), 10% solution (Gammagard Liquid/Kiovig) for the treatment of mild to moderate Alzheimer's Disease. Poster Presentation: Alzheimer's Association International Conference on Alzheimer's Disease (ICAD), Paris, France July 16-21 2011.
Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT00818662     History of Changes
Other Study ID Numbers: 160701
First Submitted: January 7, 2009
First Posted: January 8, 2009
Results First Submitted: June 27, 2014
Results First Posted: October 28, 2014
Last Update Posted: November 24, 2017