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

NCT ID: NCT00818662

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-19
• Study Completion Date: 2012-12-10

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.

Conditions

Alzheimer´s Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IGIV, 10% 400mg/kg

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

400 mg/kg bodyweight every 2 weeks for 70 weeks

IGIV, 10% 200mg/kg

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

200 mg/kg bodyweight every 2 weeks for 70 weeks

Human Albumin 0.25% Solution - 4 mL/kg

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: BIOLOGICAL

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

Human Albumin 0.25% Solution - 2 mL/kg

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: BIOLOGICAL

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

Interventions

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

400 mg/kg bodyweight every 2 weeks for 70 weeks

Intervention Type: BIOLOGICAL

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

200 mg/kg bodyweight every 2 weeks for 70 weeks

Intervention Type: BIOLOGICAL

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

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

Intervention Type: BIOLOGICAL

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

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Gammagard Liquid; KIOVIG; Gammagard Liquid

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Disease Cooperative Study (ADCS)

OTHER

Sponsor Role: collaborator

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Sun City, Arizona, United States

Tucson, Arizona, United States

Irvine, California, United States

La Jolla, California, United States

Los Angeles, California, United States

National City, California, United States

Orange, California, United States

New Haven, Connecticut, United States

Washington D.C., District of Columbia, United States

Miami Beach, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Kansas City, Kansas, United States

Lexington, Kentucky, United States

Burlington, Massachusetts, United States

Paw Paw, Michigan, United States

Rochester, Minnesota, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Liverpool, New York, United States

New York, New York, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

North Charleston, South Carolina, United States

Franklin, Tennessee, United States

Dallas, Texas, United States

Salt Lake City, Utah, United States

Madison, Wisconsin, United States

Vancouver, British Columbia, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 28381506 (View on PubMed)

Other Identifiers

160701

Identifier Type: -

Identifier Source: org_study_id