TerminatedPhase 3Results posted

Long-Term Study of IGIV, 10% in Alzheimer´s Disease

A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease

Lead sponsor

Baxalta now part of Shire

Asset

Immunoglobulin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required•MRI contraindications excluded•Brain MRI excludes superficial siderosis, vasogenic edema

Primary endpoints

•Number and Severity of Treatment-emergent Adverse Events (AEs)•Number of Infusions Temporally Associated With Adverse Events (AEs)•Number of Infusions Causally Associated With Adverse Events (AEs)

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 ID161202

NCT IDNCT01736579

Timeline

Milestones

Study first posted2012-11-29estimated

Study start2012-11-29actual

Primary completion2013-06-04actual

Study completion2013-06-04actual

Results first posted2016-08-23estimated

Last update posted2021-05-19actual

Assets

Drug assets

Immunoglobulin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Main Inclusion Criteria:

•Completed 18 months of study treatment and assessments in Baxter precursor study 160701

•Diagnosis of probable Alzheimer´s Disease (AD)

•Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability)

•Has a caregiver (study partner) who is willing and able to participate

Exclusion criteria

•Significant neurological disease other than AD

•Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack)

•Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate)

•Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae)

•Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment

•Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)

•Poorly controlled diabetes

•Serious problems with liver or kidneys

•Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin)

•Current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids)

•Recent use of investigational drugs or biologics, including those aimed at altering AD progression (with the exception of immunoglobulin)

•Active immunization for the treatment of AD at any time

There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at medinfo@baxter.com for details.

Endpoints (30)

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

Global cognition

Caregiver / quality of life

Behavior / neuropsychiatric

Function / daily living

Neuroimaging

Other (unclassified)

Global cognition

6 endpoints

Secondary/protocol endpoint

Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)

Time frame:6 months

ADAS-Cog

descriptive

Secondary/protocol endpoint

Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Mini Mental State Examination (MMSE)

Time frame:6 months

Mini-Mental State Examination (MMSE)

descriptive

Secondary/registry result

Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)

Time frame:6 months

ADAS-Cog

descriptive

Secondary/registry result

Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)

Time frame:6 months

descriptive

Secondary/registry result

Mini Mental State Examination (MMSE)

Time frame:6 months

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

2 endpoints

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)

Time frame:6 months

ADCS-Activities of Daily Living (ADCS-ADL)

ratio, descriptive

Secondary/registry result

Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)

Time frame:6 months

ADCS-Activities of Daily Living (ADCS-ADL)

ratio, descriptive

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI) Score

Time frame:6 months

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

EQ-5D Questionnaire (Proxy Version)

Time frame:6 months

descriptive

Secondary/registry result

Neuropsychiatric Inventory (NPI) Score

Time frame:6 months

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

EQ-5D Questionnaire (Proxy Version)

Time frame:6 months

descriptive

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Volumetric MRI

Time frame:6 months

descriptive

Secondary/registry result

Volumetric MRI

Time frame:6 months

descriptive

Caregiver / quality of life

6 endpoints

Secondary/protocol endpoint

Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Healthcare Resource Utilization Questionnaire (HRUQ)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Caregiver Burden Questionnaire

Time frame:6 months

descriptive

Secondary/registry result

Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)

Time frame:6 months

descriptive

Secondary/registry result

Healthcare Resource Utilization Questionnaire (HRUQ)

Time frame:6 months

descriptive

Secondary/registry result

Caregiver Burden Questionnaire

Time frame:6 months

descriptive

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Primary/protocol endpoint

Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Primary/protocol endpoint

Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Primary/protocol endpoint

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

Time frame:6 months

event count, event

Primary/registry result

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Posted result

Group	Value (number), adverse events	Reported bounds
IGIV, 10% at 0.2 g/kg Body WeightNon-serious AEs-Mildn=2 Participants	2	-
Non-serious AEs-Moderaten=2 Participants	1	-
SAEsn=2 Participants	0	-
IGIV, 10% at 0.4 g/kg Body WeightNon-serious AEs-Mildn=2 Participants	0	-
Non-serious AEs-Moderaten=2 Participants	1	-
SAEsn=2 Participants	0	-

Primary/registry result

Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Posted result

Group	Value (number), infusions	Reported bounds
IGIV, 10% at 0.2 g/kg Body Weightn=2 Participants	1	-
IGIV, 10% at 0.4 g/kg Body Weightn=2 Participants	0	-

Primary/registry result

Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:6 months

event count, event

Posted result

Group	Value (number), infusions	Reported bounds
IGIV, 10% at 0.2 g/kg Body Weightn=2 Participants	1	-
IGIV, 10% at 0.4 g/kg Body Weightn=2 Participants	1	-

Primary/registry result

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

Time frame:6 months

event count, event

Posted result

Group	Value (number), infusions	Reported bounds
IGIV, 10% at 0.2 g/kg Body Weightn=2 Participants	0	-
IGIV, 10% at 0.4 g/kg Body Weightn=2 Participants	0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Time to Skilled Nursing Facility Placement

Time frame:6 months

time to event, event

Secondary/registry result/low confidence

Time to Skilled Nursing Facility Placement

Time frame:6 months

time to event, event

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.