CompletedPhase 3Results posted

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

A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

Lead sponsor

Baxalta now part of Shire

Asset

Immunoglobulin

Listed sites

Recruiting sites

Enrollment

390

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26

Primary endpoints

•ADAS-Cog•ADCS-Activities of Daily Living (ADCS-ADL)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID160701

NCT IDNCT00818662

Timeline

Milestones

Study start2008-12-19actual

Study first posted2009-01-08estimated

Primary completion2012-12-10actual

Study completion2012-12-10actual

Results first posted2014-10-28estimated

Last update posted2021-05-19actual

Assets

Drug assets

Immunoglobulin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Main Inclusion Criteria:

•Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study

•Diagnosis of probable Alzheimer´s Disease (AD)

•Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening

•Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis

•Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability

•On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.

•If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening

Exclusion criteria

(Reasons why it might not be appropriate to participate):

•Any other forms of dementia

•Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks

2. Evidence of current bleeding in the brain by MRI

3. Serious problems with the liver or kidneys

4. Allergies to blood products

•Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:

1. Diabetes

2. Recent treatment with chemotherapy or immune suppression

3. The recent use of other investigational drugs, especially antibody therapy for AD

4. Severe headaches or psychiatric problems

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Executive function / language

Caregiver / quality of life

Global cognition

Memory

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:Baseline & 18 months

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:Baseline & 18 months

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=105 Participants	7.4	7.95
IGIV, 10% 200mg/kgn=100 Participants	8.9	8.20
Placebo 2 mL/kg or 4 mL/kgn=95 Participants	8.4	9.37

Difference in least-square means-0.895% CI-3.1 - 1.5p0.476ANCOVA

Difference in least-square means0.795% CI-1.6 - 3.0p0.530ANCOVA

Secondary/protocol endpoint

Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:Baseline & 9 months

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination

Time frame:Baseline & 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:Baseline & 9 months

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=114 Participants	2.7	5.20
IGIV, 10% 200mg/kgn=114 Participants	4.5	6.16
Placebo 2 mL/kg or 4 mL/kgn=106 Participants	3.5	6.44

Difference in least-square means-0.795% CI-2.3 - 0.8p0.368ANCOVA

Difference in least-square means0.895% CI-0.8 - 2.4p0.319ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination

Time frame:Baseline & 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=103 Participants	-12.1	13.12
IGIV, 10% 200mg/kgn=102 Participants	-15.3	12.76
Placebo 2 mL/kg or 4 mL/kgn=91 Participants	-13.5	10.95

Difference in least-square means1.995% CI-1.0 - 4.8p0.206ANCOVA

Difference in least-square means-1.495% CI-4.3 - 1.5p0.331ANCOVA

Memory

6 endpoints

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), correct responses	Standard deviation
IGIV, 10% 400mg/kgn=97 Participants	-0.8	2.00
IGIV, 10% 200mg/kgn=93 Participants	-1.2	2.21
Placebo 2 mL/kg or 4 mL/kgn=88 Participants	-1.1	1.81

Difference in least-square means0.495% CI-0.2 - 1.0p0.167ANCOVA

Difference in least-square means-0.095% CI-0.6 - 0.6p0.998ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), correct responses	Standard deviation
IGIV, 10% 400mg/kgn=94 Participants	-0.8	1.95
IGIV, 10% 200mg/kgn=89 Participants	-1.2	1.88
Placebo 2 mL/kg or 4 mL/kgn=86 Participants	-1.2	1.79

Difference in least-square means0.495% CI-0.2 - 0.9p0.173ANCOVA

Difference in least-square means0.195% CI-0.4 - 0.6p0.744ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), correct responses	Standard deviation
IGIV, 10% 400mg/kgn=80 Participants	-6.8	10.61
IGIV, 10% 200mg/kgn=63 Participants	-7.7	9.67
Placebo 2 mL/kg or 4 mL/kgn=67 Participants	-6.2	7.34

Difference in least-square means-0.695% CI-3.6 - 2.4p0.695ANCOVA

Difference in least-square means-1.395% CI-4.5 - 1.9p0.410ANCOVA

Executive function / language

8 endpoints

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), correct responses	Standard deviation
IGIV, 10% 400mg/kgn=96 Participants	-4.7	8.60
IGIV, 10% 200mg/kgn=91 Participants	-7.4	9.00
Placebo 2 mL/kg or 4 mL/kgn=85 Participants	-6.3	8.17

Difference in least-square means1.595% CI-1.0 - 4.0p0.238ANCOVA

Difference in least-square means-1.195% CI-3.6 - 1.4p0.400ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), correct responses	Standard deviation
IGIV, 10% 400mg/kgn=97 Participants	-2.8	4.06
IGIV, 10% 200mg/kgn=92 Participants	-2.2	6.84
Placebo 2 mL/kg or 4 mL/kgn=87 Participants	-2.7	3.82

Difference in least-square means-0.095% CI-1.5 - 1.5p0.988ANCOVA

Difference in least-square means0.495% CI-1.0 - 1.9p0.555ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
IGIV, 10% 400mg/kgn=83 Participants	21.6	36.93
IGIV, 10% 200mg/kgn=75 Participants	20.5	30.61
Placebo 2 mL/kg or 4 mL/kgn=74 Participants	21.3	35.50

Difference in least-square means-1.595% CI-12.2 - 9.2p0.783ANCOVA

Difference in least-square means-2.195% CI-13.1 - 8.8p0.700ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
IGIV, 10% 400mg/kgn=61 Participants	13.0	60.49
IGIV, 10% 200mg/kgn=51 Participants	28.4	65.01
Placebo 2 mL/kg or 4 mL/kgn=50 Participants	31.9	66.32

Difference in least-square means-15.295% CI-38.0 - 7.7p0.191ANCOVA

Difference in least-square means-1.695% CI-25.4 - 22.1p0.892ANCOVA

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline & 18 Months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/registry result

Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline & 18 Months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=104 Participants	-11.4	10.49
IGIV, 10% 200mg/kgn=102 Participants	-12.4	11.41
Placebo 2 mL/kg or 4 mL/kgn=95 Participants	-11.4	12.19

Difference in least-square means0.495% CI-2.9 - 3.7p0.812ANCOVA

Difference in least-square means-0.995% CI-4.3 - 2.5p0.602ANCOVA

Secondary/protocol endpoint

Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline & 9 Months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline & 9 Months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=111 Participants	-5.4	7.03
IGIV, 10% 200mg/kgn=116 Participants	-6.1	8.13
Placebo 2 mL/kg or 4 mL/kgn=107 Participants	-5.8	8.32

Difference in least-square means0.395% CI-1.8 - 2.4p0.778ANCOVA

Difference in least-square means-0.295% CI-2.3 - 1.9p0.851ANCOVA

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment

Time frame:Baseline & 18 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment

Time frame:Baseline & 18 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=104 Participants	3.7	12.93
IGIV, 10% 200mg/kgn=102 Participants	4.9	13.30
Placebo 2 mL/kg or 4 mL/kgn=94 Participants	2.4	10.77

Difference in least-square means0.795% CI-2.1 - 3.4p0.640ANCOVA

Difference in least-square means2.595% CI-0.3 - 5.3p0.075ANCOVA

Caregiver / quality of life

8 endpoints

Secondary/protocol endpoint

Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

Time frame:Baseline & 9 Months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

Time frame:Baseline & 18 Months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/registry result

Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

Time frame:Baseline & 9 Months

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgMonth 9: Very much better (1)n=114 Participants	0	-
Month 9: Much better (2)n=114 Participants	2	-
Month 9: A little better (3)n=114 Participants	7	-
Month 9: Same (4)n=114 Participants	33	-
Month 9: A little worse (5)n=114 Participants	52	-
Month 9: Much worse (6)n=114 Participants	19	-
Month 9: Very much worse (7)n=114 Participants	1	-
IGIV, 10% 200mg/kgMonth 9: Very much better (1)n=114 Participants	0	-
Month 9: Much better (2)n=114 Participants	1	-
Month 9: A little better (3)n=114 Participants	3	-
Month 9: Same (4)n=114 Participants	33	-
Month 9: A little worse (5)n=114 Participants	56	-
Month 9: Much worse (6)n=114 Participants	18	-
Month 9: Very much worse (7)n=114 Participants	3	-
Placebo 2 mL/kg or 4 mL/kgMonth 9: Very much better (1)n=104 Participants	0	-
Month 9: Much better (2)n=104 Participants	1	-
Month 9: A little better (3)n=104 Participants	7	-
Month 9: Same (4)n=104 Participants	36	-
Month 9: A little worse (5)n=104 Participants	48	-
Month 9: Much worse (6)n=104 Participants	12	-
Month 9: Very much worse (7)n=104 Participants	0	-

Difference in least-square means0.195% CI-0.1 - 0.3p0.306Mixed Models Analysis

Difference in least-square means0.395% CI0.0 - 0.5p0.028Mixed Models Analysis

Secondary/registry result

Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

Time frame:Baseline & 18 Months

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgMonth 18: Very much better (1)n=105 Participants	0	-
Month 18: Much better (2)n=105 Participants	1	-
Month 18: A little better (3)n=105 Participants	6	-
Month 18: Same (4)n=105 Participants	15	-
Month 18: A little worse (5)n=105 Participants	44	-
Month 18: Much worse (6)n=105 Participants	32	-
Month 18: Very much worse (7)n=105 Participants	7	-
IGIV, 10% 200mg/kgMonth 18: Very much better (1)n=101 Participants	0	-
Month 18: Much better (2)n=101 Participants	2	-
Month 18: A little better (3)n=101 Participants	1	-
Month 18: Same (4)n=101 Participants	15	-
Month 18: A little worse (5)n=101 Participants	43	-
Month 18: Much worse (6)n=101 Participants	33	-
Month 18: Very much worse (7)n=101 Participants	7	-
Placebo 2 mL/kg or 4 mL/kgMonth 18: Very much better (1)n=92 Participants	0	-
Month 18: Much better (2)n=92 Participants	1	-
Month 18: A little better (3)n=92 Participants	3	-
Month 18: Same (4)n=92 Participants	16	-
Month 18: A little worse (5)n=92 Participants	36	-
Month 18: Much worse (6)n=92 Participants	32	-
Month 18: Very much worse (7)n=92 Participants	4	-

Difference in least-square means-0.195% CI-0.3 - 0.2p0.660Mixed Models Analysis

Difference in least-square means0.095% CI-0.2 - 0.3p0.766Mixed Models Analysis

Secondary/registry result

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=99 Participants	-0.5	5.34
IGIV, 10% 200mg/kgn=99 Participants	-0.7	4.40
Placebo 2 mL/kg or 4 mL/kgn=86 Participants	-1.5	5.20

Difference in least-square means1.195% CI-0.2 - 2.3p0.093ANCOVA

Difference in least-square means1.195% CI-0.2 - 2.3p0.094ANCOVA

Secondary/registry result

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=99 Participants	-3.0	4.97
IGIV, 10% 200mg/kgn=99 Participants	-2.5	5.17
Placebo 2 mL/kg or 4 mL/kgn=92 Participants	-1.6	5.12

Difference in least-square means-1.195% CI-2.3 - 0.2p0.096ANCOVA

Difference in least-square means-1.095% CI-2.2 - 0.3p0.123ANCOVA

Safety / tolerability / PK

14 endpoints

Secondary/protocol endpoint

Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint

Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Time frame:During or within 72 hours of completion of an infusion

event count, event

Secondary/protocol endpoint

Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint

Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)

Time frame:Throughout each infusion period

event count, event

Secondary/registry result

Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgBlood and Lymphatic System Disordersn=127 Participants	7	-
Cardiac Disordersn=127 Participants	1	-
Eye Disordersn=127 Participants	1	-
Gastrointestinal Disordersn=127 Participants	10	-
General Disorders & Administration Site Conditionsn=127 Participants	22	-
Immune System Disordersn=127 Participants	0	-
Infections and Infestationsn=127 Participants	1	-
Injury, Poisoning, and Procedural Complicationsn=127 Participants	5	-
Investigationsn=127 Participants	15	-
Metabolism and Nutrition Disordersn=127 Participants	0	-
Musculoskeletal and Connective Tissue Disordersn=127 Participants	7	-
Nervous System Disordersn=127 Participants	33	-
Psychiatric Disordersn=127 Participants	5	-
Reproductive System and Breast Disordersn=127 Participants	0	-
Respiratory, Thoracic and Mediastinal Disordersn=127 Participants	3	-
Skin and Subcutaneous Tissue Disordersn=127 Participants	26	-
Vascular Disordersn=127 Participants	10	-
IGIV, 10% 200mg/kgBlood and Lymphatic System Disordersn=135 Participants	2	-
Cardiac Disordersn=135 Participants	0	-
Eye Disordersn=135 Participants	1	-
Gastrointestinal Disordersn=135 Participants	13	-
General Disorders & Administration Site Conditionsn=135 Participants	32	-
Immune System Disordersn=135 Participants	1	-
Infections and Infestationsn=135 Participants	1	-
Injury, Poisoning, and Procedural Complicationsn=135 Participants	1	-
Investigationsn=135 Participants	16	-
Metabolism and Nutrition Disordersn=135 Participants	1	-
Musculoskeletal and Connective Tissue Disordersn=135 Participants	5	-
Nervous System Disordersn=135 Participants	34	-
Psychiatric Disordersn=135 Participants	6	-
Reproductive System and Breast Disordersn=135 Participants	1	-
Respiratory, Thoracic and Mediastinal Disordersn=135 Participants	4	-
Skin and Subcutaneous Tissue Disordersn=135 Participants	20	-
Vascular Disordersn=135 Participants	18	-
Placebo 2 mL/kg or 4 mL/kgBlood and Lymphatic System Disordersn=121 Participants	1	-
Cardiac Disordersn=121 Participants	4	-
Eye Disordersn=121 Participants	0	-
Gastrointestinal Disordersn=121 Participants	7	-
General Disorders & Administration Site Conditionsn=121 Participants	13	-
Immune System Disordersn=121 Participants	0	-
Infections and Infestationsn=121 Participants	1	-
Injury, Poisoning, and Procedural Complicationsn=121 Participants	0	-
Investigationsn=121 Participants	13	-
Metabolism and Nutrition Disordersn=121 Participants	0	-
Musculoskeletal and Connective Tissue Disordersn=121 Participants	0	-
Nervous System Disordersn=121 Participants	24	-
Psychiatric Disordersn=121 Participants	2	-
Reproductive System and Breast Disordersn=121 Participants	0	-
Respiratory, Thoracic and Mediastinal Disordersn=121 Participants	4	-
Skin and Subcutaneous Tissue Disordersn=121 Participants	9	-
Vascular Disordersn=121 Participants	17	-

Secondary/registry result

Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgCardiac Disordersn=127 Participants	1	-
General Disorders & Administration Site Conditionsn=127 Participants	0	-
Immune System Disordersn=127 Participants	0	-
Investigationsn=127 Participants	0	-
Nervous System Disordersn=127 Participants	1	-
Psychiatric Disordersn=127 Participants	0	-
Respiratory, Thoracic and Mediastinal Disordersn=127 Participants	0	-
Vascular Disordersn=127 Participants	0	-
IGIV, 10% 200mg/kgCardiac Disordersn=135 Participants	0	-
General Disorders & Administration Site Conditionsn=135 Participants	0	-
Immune System Disordersn=135 Participants	1	-
Investigationsn=135 Participants	2	-
Nervous System Disordersn=135 Participants	2	-
Psychiatric Disordersn=135 Participants	1	-
Respiratory, Thoracic and Mediastinal Disordersn=135 Participants	1	-
Vascular Disordersn=135 Participants	0	-
Placebo 2 mL/kg or 4 mL/kgCardiac Disordersn=121 Participants	1	-
General Disorders & Administration Site Conditionsn=121 Participants	1	-
Immune System Disordersn=121 Participants	0	-
Investigationsn=121 Participants	0	-
Nervous System Disordersn=121 Participants	0	-
Psychiatric Disordersn=121 Participants	0	-
Respiratory, Thoracic and Mediastinal Disordersn=121 Participants	1	-
Vascular Disordersn=121 Participants	2	-

Secondary/registry result

Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgBlood and Lymphatic System Disordersn=127 Participants	13	-
Cardiac Disordersn=127 Participants	3	-
Ear and Labyrinth Disordersn=127 Participants	4	-
Endocrine Disordersn=127 Participants	1	-
Eye Disordersn=127 Participants	14	-
Gastrointestinal Disordersn=127 Participants	47	-
General Disorders & Administration Site Conditionsn=127 Participants	57	-
Immune System Disordersn=127 Participants	1	-
Infections and Infestationsn=127 Participants	40	-
Injury, Poisoning, and Procedural Complicationsn=127 Participants	36	-
Investigationsn=127 Participants	37	-
Metabolism and Nutrition Disordersn=127 Participants	14	-
Musculoskeletal and Connective Tissue Disordersn=127 Participants	40	-
Neoplasms, Benign, Malignant and Unspecifiedn=127 Participants	8	-
Nervous System Disordersn=127 Participants	63	-
Psychiatric Disordersn=127 Participants	41	-
Renal and Urinary Disordersn=127 Participants	13	-
Reproductive System and Breast Disordersn=127 Participants	5	-
Respiratory, Thoracic and Mediastinal Disordersn=127 Participants	23	-
Skin and Subcutaneous Tissue Disordersn=127 Participants	49	-
Social Circumstancesn=127 Participants	0	-
Surgical and Medical Proceduresn=127 Participants	8	-
Vascular Disordersn=127 Participants	22	-
IGIV, 10% 200mg/kgBlood and Lymphatic System Disordersn=135 Participants	7	-
Cardiac Disordersn=135 Participants	11	-
Ear and Labyrinth Disordersn=135 Participants	3	-
Endocrine Disordersn=135 Participants	0	-
Eye Disordersn=135 Participants	5	-
Gastrointestinal Disordersn=135 Participants	51	-
General Disorders & Administration Site Conditionsn=135 Participants	66	-
Immune System Disordersn=135 Participants	7	-
Infections and Infestationsn=135 Participants	46	-
Injury, Poisoning, and Procedural Complicationsn=135 Participants	37	-
Investigationsn=135 Participants	48	-
Metabolism and Nutrition Disordersn=135 Participants	15	-
Musculoskeletal and Connective Tissue Disordersn=135 Participants	44	-
Neoplasms, Benign, Malignant and Unspecifiedn=135 Participants	8	-
Nervous System Disordersn=135 Participants	73	-
Psychiatric Disordersn=135 Participants	49	-
Renal and Urinary Disordersn=135 Participants	16	-
Reproductive System and Breast Disordersn=135 Participants	4	-
Respiratory, Thoracic and Mediastinal Disordersn=135 Participants	35	-
Skin and Subcutaneous Tissue Disordersn=135 Participants	52	-
Social Circumstancesn=135 Participants	1	-
Surgical and Medical Proceduresn=135 Participants	6	-
Vascular Disordersn=135 Participants	30	-
Placebo 2 mL/kg or 4 mL/kgBlood and Lymphatic System Disordersn=121 Participants	5	-
Cardiac Disordersn=121 Participants	15	-
Ear and Labyrinth Disordersn=121 Participants	5	-
Endocrine Disordersn=121 Participants	1	-
Eye Disordersn=121 Participants	9	-
Gastrointestinal Disordersn=121 Participants	36	-
General Disorders & Administration Site Conditionsn=121 Participants	52	-
Immune System Disordersn=121 Participants	3	-
Infections and Infestationsn=121 Participants	57	-
Injury, Poisoning, and Procedural Complicationsn=121 Participants	50	-
Investigationsn=121 Participants	30	-
Metabolism and Nutrition Disordersn=121 Participants	16	-
Musculoskeletal and Connective Tissue Disordersn=121 Participants	27	-
Neoplasms, Benign, Malignant and Unspecifiedn=121 Participants	13	-
Nervous System Disordersn=121 Participants	53	-
Psychiatric Disordersn=121 Participants	49	-
Renal and Urinary Disordersn=121 Participants	12	-
Reproductive System and Breast Disordersn=121 Participants	3	-
Respiratory, Thoracic and Mediastinal Disordersn=121 Participants	23	-
Skin and Subcutaneous Tissue Disordersn=121 Participants	31	-
Social Circumstancesn=121 Participants	0	-
Surgical and Medical Proceduresn=121 Participants	8	-
Vascular Disordersn=121 Participants	31	-

Secondary/registry result

Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgBlood and Lymphatic System Disordersn=127 Participants	2	-
Cardiac Disordersn=127 Participants	5	-
Ear and Labyrinth Disordersn=127 Participants	1	-
Gastrointestinal Disordersn=127 Participants	5	-
General Disorders & Administration Site Conditionsn=127 Participants	2	-
Hepatobiliary Disordersn=127 Participants	0	-
Immune System Disordersn=127 Participants	0	-
Infections and Infestationsn=127 Participants	2	-
Injury, Poisoning, and Procedural Complicationsn=127 Participants	3	-
Investigationsn=127 Participants	1	-
Metabolism and Nutrition Disordersn=127 Participants	1	-
Musculoskeletal and Connective Tissue Disordersn=127 Participants	2	-
Neoplasms, Benign, Malignant and Unspecifiedn=127 Participants	0	-
Nervous System Disordersn=127 Participants	3	-
Psychiatric Disordersn=127 Participants	2	-
Renal and Urinary Disordersn=127 Participants	0	-
Respiratory, Thoracic and Mediastinal Disordersn=127 Participants	1	-
Surgical and Medical Proceduresn=127 Participants	0	-
Vascular Disordersn=127 Participants	4	-
IGIV, 10% 200mg/kgBlood and Lymphatic System Disordersn=135 Participants	0	-
Cardiac Disordersn=135 Participants	3	-
Ear and Labyrinth Disordersn=135 Participants	0	-
Gastrointestinal Disordersn=135 Participants	1	-
General Disorders & Administration Site Conditionsn=135 Participants	4	-
Hepatobiliary Disordersn=135 Participants	1	-
Immune System Disordersn=135 Participants	1	-
Infections and Infestationsn=135 Participants	2	-
Injury, Poisoning, and Procedural Complicationsn=135 Participants	2	-
Investigationsn=135 Participants	2	-
Metabolism and Nutrition Disordersn=135 Participants	1	-
Musculoskeletal and Connective Tissue Disordersn=135 Participants	3	-
Neoplasms, Benign, Malignant and Unspecifiedn=135 Participants	3	-
Nervous System Disordersn=135 Participants	6	-
Psychiatric Disordersn=135 Participants	4	-
Renal and Urinary Disordersn=135 Participants	1	-
Respiratory, Thoracic and Mediastinal Disordersn=135 Participants	2	-
Surgical and Medical Proceduresn=135 Participants	1	-
Vascular Disordersn=135 Participants	0	-
Placebo 2 mL/kg or 4 mL/kgBlood and Lymphatic System Disordersn=121 Participants	1	-
Cardiac Disordersn=121 Participants	3	-
Ear and Labyrinth Disordersn=121 Participants	0	-
Gastrointestinal Disordersn=121 Participants	1	-
General Disorders & Administration Site Conditionsn=121 Participants	2	-
Hepatobiliary Disordersn=121 Participants	1	-
Immune System Disordersn=121 Participants	0	-
Infections and Infestationsn=121 Participants	4	-
Injury, Poisoning, and Procedural Complicationsn=121 Participants	2	-
Investigationsn=121 Participants	1	-
Metabolism and Nutrition Disordersn=121 Participants	2	-
Musculoskeletal and Connective Tissue Disordersn=121 Participants	0	-
Neoplasms, Benign, Malignant and Unspecifiedn=121 Participants	3	-
Nervous System Disordersn=121 Participants	5	-
Psychiatric Disordersn=121 Participants	3	-
Renal and Urinary Disordersn=121 Participants	1	-
Respiratory, Thoracic and Mediastinal Disordersn=121 Participants	3	-
Surgical and Medical Proceduresn=121 Participants	1	-
Vascular Disordersn=121 Participants	4	-

Secondary/registry result

Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Time frame:During or within 72 hours of completion of an infusion

event count, event

Posted result

Group	Value (number), Infusions	Reported bounds
IGIV, 10% 400mg/kgn=127 Participants	396	-
IGIV, 10% 200mg/kgn=135 Participants	467	-
Placebo 2 mL/kg or 4 mL/kgn=121 Participants	349	-

Secondary/registry result

Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), Infusions	Reported bounds
IGIV, 10% 400mg/kgn=127 Participants	225	-
IGIV, 10% 200mg/kgn=135 Participants	265	-
Placebo 2 mL/kg or 4 mL/kgn=121 Participants	172	-

Secondary/registry result

Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)

Time frame:Throughout each infusion period

event count, event

Posted result

Group	Value (number), Adverse events	Reported bounds
IGIV, 10% 400mg/kgn=127 Participants	48	-
IGIV, 10% 200mg/kgn=135 Participants	28	-
Placebo 2 mL/kg or 4 mL/kgn=121 Participants	36	-

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test

Time frame:Baseline & 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants Experiencing a Clinically Significant Rash

Time frame:Throughout the study period, approximately 4 years

event count, event

Secondary/registry result/low confidence

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test

Time frame:Baseline & 18 months

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
IGIV, 10% 400mg/kgn=94 Participants	-0.7	1.27
IGIV, 10% 200mg/kgn=90 Participants	-0.7	1.15
Placebo 2 mL/kg or 4 mL/kgn=85 Participants	-0.6	1.17

Difference in least-square means-0.195% CI-0.4 - 0.2p0.588ANCOVA

Difference in least-square means-0.295% CI-0.5 - 0.2p0.351ANCOVA

Secondary/registry result/low confidence

Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgn=127 Participants	31	-
IGIV, 10% 200mg/kgn=135 Participants	24	-
Placebo 2 mL/kg or 4 mL/kgn=121 Participants	16	-

Secondary/registry result/low confidence

Number of Participants Experiencing a Clinically Significant Rash

Time frame:Throughout the study period, approximately 4 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
IGIV, 10% 400mg/kgRash requiring discontinuation from treatmentn=127 Participants	3	-
Rash requiring systemic therapyn=127 Participants	19	-
IGIV, 10% 200mg/kgRash requiring discontinuation from treatmentn=135 Participants	2	-
Rash requiring systemic therapyn=135 Participants	16	-
Placebo 2 mL/kg or 4 mL/kgRash requiring discontinuation from treatmentn=121 Participants	0	-
Rash requiring systemic therapyn=121 Participants	8	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Relkin NR, Thomas RG, Rissman RA, Brewer JB, Rafii MS, van Dyck CH, Jack CR, Sano M, Knopman DS, Raman R, Szabo P, Gelmont DM, Fritsch S, Aisen PS; Alzheimer's Disease Cooperative Study. A phase 3 trial of IV immunoglobulin for Alzheimer disease. Neurology. 2017 May 2;88(18):1768-1775. doi: 10.1212/WNL.0000000000003904. Epub 2017 Apr 5.
PMID28381506via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.