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

Primary Purpose

Alzheimer´s Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg

Placebo solution: Human Albumin 0.25% - 4 mL/kg

Placebo solution: Human Albumin 0.25% - 2 mL/kg

About this trial

This is an interventional treatment trial for Alzheimer´s Disease focused on measuring Alzheimer´s, Dementia, Dementia of Alzheimer Type, Immunoglobulins, Gammaglobulins, Immune Globulin Intravenous (IGIV), Intravenous Immune Globulin (IVIG), Antibodies, Amyloid, Immunotherapy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Main 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

IGIV, 10% 400mg/kg

IGIV, 10% 200mg/kg

Human Albumin 0.25% Solution - 4 mL/kg

Human Albumin 0.25% Solution - 2 mL/kg

Arm Description

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

0.25% human albumin solution infused at 4 mL/kg/2weeks

0.25% human albumin solution infused at 2 mL/kg/2weeks

Outcomes

Primary Outcome Measures

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

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 each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

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

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.

Secondary Outcome Measures

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

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

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

The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse

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

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

The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.

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

The NPI is a validated instrument used to assess behavioral psychopathology in AD; 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.

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

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.

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

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

This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.

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

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

In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as 'acts,' 'acted,' 'acting'). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

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

WAIS-R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

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

In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category "animals" as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

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

This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.

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

This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.

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

In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to 'ten after eleven.' Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).

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

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

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

Related and unrelated non-SAEs

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

Related and unrelated SAEs

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

Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)

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

Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered

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

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

Number of Participants Experiencing a Clinically Significant Rash

Participants requiring systemic therapy or discontinuation from further treatment

Full Information

NCT ID

NCT00818662

First Posted

January 7, 2009

Last Updated

April 30, 2021

Sponsor

Baxalta now part of Shire

Collaborators

Alzheimer's Disease Cooperative Study (ADCS)

1. Study Identification

Unique Protocol Identification Number

NCT00818662

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 19, 2008 (Actual)

Primary Completion Date

December 10, 2012 (Actual)

Study Completion Date

December 10, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxalta now part of Shire

Collaborators

Alzheimer's Disease Cooperative Study (ADCS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).

Detailed Description

Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer´s Disease

Keywords

Alzheimer´s, Dementia, Dementia of Alzheimer Type, Immunoglobulins, Gammaglobulins, Immune Globulin Intravenous (IGIV), Intravenous Immune Globulin (IVIG), Antibodies, Amyloid, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IGIV, 10% 400mg/kg

Arm Type

Experimental

Arm Description

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Arm Title

IGIV, 10% 200mg/kg

Arm Type

Experimental

Arm Description

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Arm Title

Human Albumin 0.25% Solution - 4 mL/kg

Arm Type

Placebo Comparator

Arm Description

0.25% human albumin solution infused at 4 mL/kg/2weeks

Arm Title

Human Albumin 0.25% Solution - 2 mL/kg

Arm Type

Placebo Comparator

Arm Description

0.25% human albumin solution infused at 2 mL/kg/2weeks

Intervention Type

Biological

Intervention Name(s)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg

Other Intervention Name(s)

Gammagard Liquid, KIOVIG

Intervention Description

400 mg/kg bodyweight every 2 weeks for 70 weeks

Intervention Type

Biological

Intervention Name(s)

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg

Other Intervention Name(s)

Gammagard Liquid

Intervention Description

200 mg/kg bodyweight every 2 weeks for 70 weeks

Intervention Type

Biological

Intervention Name(s)

Placebo solution: Human Albumin 0.25% - 4 mL/kg

Intervention Description

Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks

Intervention Type

Biological

Intervention Name(s)

Placebo solution: Human Albumin 0.25% - 2 mL/kg

Intervention Description

Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 Months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline & 9 months

Title

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

Description

Time Frame

Baseline & 9 Months

Title

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

Description

Time Frame

Baseline & 9 Months

Title

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

Description

Time Frame

Baseline & 18 Months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Description

This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.

Time Frame

Baseline & 18 months

Title

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

Description

Time Frame

Baseline & 18 months

Title

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

Title

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

Time Frame

Throughout the study period, approximately 4 years

Title

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

Description

Related and unrelated non-SAEs

Time Frame

Throughout the study period, approximately 4 years

Title

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

Description

Related and unrelated SAEs

Time Frame

Throughout the study period, approximately 4 years

Title

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

Description

Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)

Time Frame

During or within 72 hours of completion of an infusion

Title

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

Description

Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered

Time Frame

Throughout the study period, approximately 4 years

Title

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

Time Frame

Throughout each infusion period

Title

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

Title

Number of Participants Experiencing a Clinically Significant Rash

Description

Participants requiring systemic therapy or discontinuation from further treatment

Time Frame

Throughout the study period, approximately 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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 Main 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: Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks Evidence of current bleeding in the brain by MRI Serious problems with the liver or kidneys Allergies to blood products Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as: Diabetes Recent treatment with chemotherapy or immune suppression The recent use of other investigational drugs, especially antibody therapy for AD Severe headaches or psychiatric problems

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

Country

United States

City

Phoenix

State/Province

Arizona

Country

United States

City

Sun City

State/Province

Arizona

Country

United States

City

Tucson

State/Province

Arizona

Country

United States

City

Irvine

State/Province

California

Country

United States

City

La Jolla

State/Province

California

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

National City

State/Province

California

Country

United States

City

Orange

State/Province

California

Country

United States

City

New Haven

State/Province

Connecticut

Country

United States

City

Washington

State/Province

District of Columbia

Country

United States

City

Miami Beach

State/Province

Florida

Country

United States

City

Sarasota

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

Chicago

State/Province

Illinois

Country

United States

City

Iowa City

State/Province

Iowa

Country

United States

City

Kansas City

State/Province

Kansas

Country

United States

City

Lexington

State/Province

Kentucky

Country

United States

City

Burlington

State/Province

Massachusetts

Country

United States

City

Paw Paw

State/Province

Michigan

Country

United States

City

Rochester

State/Province

Minnesota

Country

United States

City

Saint Louis

State/Province

Missouri

Country

United States

City

Omaha

State/Province

Nebraska

Country

United States

City

Las Vegas

State/Province

Nevada

Country

United States

City

Liverpool

State/Province

New York

Country

United States

City

New York

State/Province

New York

Country

United States

City

Rochester

State/Province

New York

Country

United States

City

Cleveland

State/Province

Ohio

Country

United States

City

Tulsa

State/Province

Oklahoma

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Providence

State/Province

Rhode Island

Country

United States

City

North Charleston

State/Province

South Carolina

Country

United States

City

Franklin

State/Province

Tennessee

Country

United States

City

Dallas

State/Province

Texas

Country

United States

City

Salt Lake City

State/Province

Utah

Country

United States

City

Madison

State/Province

Wisconsin

Country

United States

City

Vancouver

State/Province

British Columbia

Country

Canada

City

London

State/Province

Ontario

Country

Canada

City

Toronto

State/Province

Ontario

Country

Canada

City

Montreal

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Citations:

Citation

Relkin N, Gessert D, Stokes K, Adamiak B, Ngo LY, Thomas R, Gelmont D, Aisen P. The Gammaglobulin Alzheimer Partnership Study (GAP): Design, screening, enrollment and futility analysis results. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 8[4 Suppl], P456. 2012.

Results Reference

background

Citation

Ngo L, Adamiak B, Gelmont D. A confirmatory phase 3 randomized, double-blind, placebo-controlled study of the safety and effectiveness of immune globulin intravenous (human), 10% solution (Gammagard Liquid/Kiovig) for the treatment of mild to moderate Alzheimer's Disease. Poster Presentation: Alzheimer's Association International Conference on Alzheimer's Disease (ICAD), Paris, France July 16-21 2011.

Results Reference

background

PubMed Identifier

28381506

Citation

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.

Results Reference

derived

Learn more about this trial

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

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