Phase 3 IGIV, 10% in Alzheimer´s Disease

This study has been terminated.

(The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.)

Sponsor:

Information provided by (Responsible Party):

Baxalta US Inc.

ClinicalTrials.gov Identifier:

NCT01524887

First received: January 20, 2012

Last updated: June 26, 2015

Last verified: February 2015

History of Changes

Results First Received: February 3, 2015

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% Solution Biological: Human albumin 0.25%

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
Enrollment was conducted at 58 clinical sites worldwide.

Pre-Assignment Details

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

Reporting Groups

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

Participant Flow: Overall Study

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

[1]	No subject completed the study as Baxter Healthcare terminated the study early.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population 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
Number of Participants [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

Outcome Measures

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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) ]

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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) ]

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3. Secondary:

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

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4. Secondary:

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

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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) ]

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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) ]

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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) ]

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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 ]

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9. Secondary:

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

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10. Secondary:

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

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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 ]

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12. Secondary:

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

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13. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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

More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (eg, for intellectual property protection).

Results Point of Contact:

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

Responsible Party:	Baxalta US Inc.
ClinicalTrials.gov Identifier:	NCT01524887 History of Changes
Other Study ID Numbers:	161003 2011-000914-21 ( EudraCT Number )
Study First Received:	January 20, 2012
Results First Received:	February 3, 2015
Last Updated:	June 26, 2015
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Belgium: Federal Agency for Medicinal Products and Health Products United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines Germany: Paul-Ehrlich-Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Australia: Department of Health and Ageing Therapeutic Goods Administration Japan: Pharmaceuticals and Medical Devices Agency

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