Phase 3 IGIV, 10% in Alzheimer´s Disease

Recruitment Details

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

Pre-Assignment Details

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

Reporting Groups

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

Participant Flow:   Overall Study

	IGIV, 10% at High Dose (0.4 g/kg)	IGIV, 10% at Low Dose (0.2 g/kg)	Placebo Control
STARTED	85	90	86
Received Treatment	83	85	83
COMPLETED	0 [1]	0 [1]	0 [1]
NOT COMPLETED	85	90	86
Withdrawal by Subject	6	2	3
Adverse Event	5	1	1
Protocol Violation	0	0	1
Study termination	73	87	79
Withdrawal by Caregiver	0	0	2
Use of prohibited medication	1	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population comprises treated subjects (=safety analysis set).

Reporting Groups

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

Baseline Measures

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

1.  Primary:

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

2.  Primary:

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

3.  Secondary:

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

4.  Secondary:

Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline to 9 Months (actual time frame) ]

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

Number of Participants Experiencing Any AEs and/or SAEs   [ Time Frame: Throughout the study period: 18 Months ]

10.  Secondary:

Number of Infusions Temporally Associated With AEs and/or SAEs   [ Time Frame: During or within 72 hours of completion of an infusion ]

11.  Secondary:

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

12.  Secondary:

Number of Infusions Causally Associated With AEs and/or SAEs   [ Time Frame: Throughout the study period: 18 Months ]

13.  Secondary:

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

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The primary and secondary outcome measures were originally planned to be assessed at 18 months. However, as the study was terminated early, an analysis was completed at 9 months instead, in a subset of subjects who had received 9 months of treatment.