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 Alzheimer´s 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
|