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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

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer´s Disease

Intervention: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg (Biological); Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg (Biological); Placebo solution: Human Albumin 0.25% - 4 mL/kg (Biological); Placebo solution: Human Albumin 0.25% - 2 mL/kg (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Norman Relkin, MD, PhD, Study Director, Affiliation: Alzheimer's Disease Cooperative Study (ADCS)
David Gelmont, MD, Study Director, Affiliation: Baxter Healthcare Corporation

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).

Clinical Details

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 Alzheimers Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Eligibility

Minimum age: 50 Years. Maximum age: 89 Years. Gender(s): Both.

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:

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

Locations and Contacts

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Sun City, Arizona, United States

Tucson, Arizona, United States

Vancouver, British Columbia, Canada

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, 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

London, Ontario, Canada

Toronto, Ontario, Canada

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Montreal, Quebec, Canada

Providence, Rhode Island, United States

N. Charleston, South Carolina, United States

Franklin, Tennessee, United States

Dallas, Texas, United States

Salt Lake City, Utah, United States

Madison, Wisconsin, United States

Additional Information

Related publications:

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.

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.

Starting date: December 2008
Last updated: June 26, 2015

Page last updated: August 23, 2015

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