## Protocol Section
### Identification Module
**NCT ID:** NCT01736579

**Brief Title:** Long-Term Study of IGIV, 10% in Alzheimer´s Disease

**Official Title:** 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

#### Organization Study ID Info
**ID:** 161202
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
### Status Module
#### Completion Date
**Date:** 2013-06-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-19

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-30

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-06-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-08-23

**Type:** ESTIMATED

**Results First Submit Date:** 2016-07-13

**Results First Submit QC Date:** 2016-07-13

#### Start Date
**Date:** 2012-11-29

**Type:** ACTUAL

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2012-11-29
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-27
**Study First Submit QC Date:** 2012-11-27
**Why Stopped:** 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 Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Baxalta now part of Shire

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.

### Conditions Module

**Conditions:**

- Alzheimer´s Disease

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.

**Intervention Names:**

- Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

**Label:** IGIV, 10% at 0.2 g/kg body weight

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months

**Intervention Names:**

- Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

**Label:** IGIV, 10% at 0.4 g/kg body weight

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IGIV, 10% at 0.2 g/kg body weight

- IGIV, 10% at 0.4 g/kg body weight

**Name:** Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

**Other Names:**

- Gammagard Liquid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 6 months

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

**Time Frame:** 6 months

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

**Time Frame:** 6 months

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

**Time Frame:** 6 months

#### Secondary Outcomes

**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 the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.

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

**Time Frame:** 6 months

**Description:** The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.

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

**Time Frame:** 6 months

**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.

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

**Time Frame:** 6 months

**Description:** The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.

**Measure:** Mini Mental State Examination (MMSE)

**Time Frame:** 6 months

**Description:** The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; 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.

**Measure:** Neuropsychiatric Inventory (NPI) Score

**Time Frame:** 6 months

**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.

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

**Time Frame:** 6 months

**Description:** EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state \[100\] to worst imaginable health state \[0\]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.

**Measure:** EQ-5D Questionnaire (Proxy Version)

**Time Frame:** 6 months

**Description:** The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.

**Measure:** Healthcare Resource Utilization Questionnaire (HRUQ)

**Time Frame:** 6 months

**Description:** The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.

**Measure:** Caregiver Burden Questionnaire

**Time Frame:** 6 months

**Description:** Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.

**Measure:** Time to Skilled Nursing Facility Placement

**Time Frame:** 6 months

**Description:** Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.

**Measure:** Volumetric MRI

**Time Frame:** 6 months

### Eligibility Module

**Eligibility 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

Main 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.

**Minimum Age:** 51 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rochester

**Country:** United States

**State:** New York

#### Overall Officials

**Official 1:**

**Affiliation:** Takeda

**Name:** Study Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003704

- Term: Dementia

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Cap

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Cap

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: HIGH

- As Found: Active exercises

- ID: M8836

- Name: gamma-Globulins

- Relevance: HIGH

- As Found: Dronabinol

- ID: M20191

- Name: Rho(D) Immune Globulin

- Relevance: HIGH

- As Found: Dronabinol

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007136

- Term: Immunoglobulins

- ID: D000000906

- Term: Antibodies

- ID: D000005719

- Term: gamma-Globulins

- ID: D000016756

- Term: Immunoglobulins, Intravenous

- ID: D000018029

- Term: Rho(D) Immune Globulin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** IGIV, 10% at 0.2 g/kg Body Weight

**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks.

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 2

**Serious Number At Risk:** 2

**Title:** IGIV, 10% at 0.2 g/kg Body Weight

**Group ID:** EG001

**Title:** IGIV, 10% at 0.4 g/kg Body Weight

**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks.

**ID:** EG001

**Other Num Affected:** 1

**Other Num at Risk:** 2

**Serious Number At Risk:** 2

**Title:** IGIV, 10% at 0.4 g/kg Body Weight

**Frequency Threshold:** 5

#### Other Events

**Term:** Infusion Site Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA

**Term:** Tooth Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA

**Term:** Blood Pressure Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA

**Term:** Urticaria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA

**Time Frame:** Throughout the study period (6 months)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 2

**Group ID:** BG001

**Value:** 2

**Group ID:** BG002

**Value:** 4

**Units:** Participants

### Group

**ID:** BG000

**Title:** IGIV, 10% at 0.2 g/kg Body Weight

**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks

### Group

**ID:** BG001

**Title:** IGIV, 10% at 0.4 g/kg Body Weight

**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Baxalta's 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 or 12 months after study completion. Baxalta requires a review of results communications (eg, for confidential information) ≥30 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** This study was an extension of study 160701 and was stopped early due to lack of evidence of clinical benefit of IGIV treatment in Alzheimer's Disease patients in Baxalta study 160701. Summary tables available for safety data only.
### Point of Contact
**Email:** ClinicalTransparency@shire.com
**Organization:** Shire
**Phone:** +1 866 842 5335
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
#### Outcome Measure 9
#### Outcome Measure 10
#### Outcome Measure 11
#### Outcome Measure 12
#### Outcome Measure 13
#### Outcome Measure 14
#### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Unit of Measure:** adverse events
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 3
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 5
**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 the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 6
**Description:** The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 7
**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.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 8
**Description:** The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Mini Mental State Examination (MMSE)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 9
**Description:** The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; 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.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Neuropsychiatric Inventory (NPI) Score
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 10
**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.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 11
**Description:** EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state \[100\] to worst imaginable health state \[0\]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** EQ-5D Questionnaire (Proxy Version)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 12
**Description:** The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Healthcare Resource Utilization Questionnaire (HRUQ)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 13
**Description:** The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Caregiver Burden Questionnaire
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 14
**Description:** Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Time to Skilled Nursing Facility Placement
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 15
**Description:** Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Volumetric MRI
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
### Participant Flow Module
#### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** FG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
#### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** FG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Termination of Study by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Pre-Assignment Details:** Six participants were enrolled (i.e. signed informed consent form), of which 2 failed screening and 4 were treated with study product.
**Recruitment Details:** Enrollment was conducted at one clinical site in the US.
**Has Results:** True