Trial record 7 of 12 for:    intravenous immunoglobulin | alzheimer

Phase 3 IGIV, 10% in Alzheimer´s Disease

This study has been terminated.
(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:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01524887
First received: January 20, 2012
Last updated: May 19, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.


Condition Intervention Phase
Alzheimer´s Disease
Biological: Immune Globulin Intravenous (Human), 10% Solution
Biological: Human albumin 0.25%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) for the Treatment of Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Cognitive subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog) [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, and 18 Months ] [ Designated as safety issue: No ]
  • Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) inventory [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, and 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADCS-Clinical Global Impression of Change (CGIC) [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, and 18 Months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, and 18 Months ] [ Designated as safety issue: No ]
  • Change in volumetric magnetic resonance imaging (MRI) parameters [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
  • Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Baseline, 6 Months, 9 Months, 12 Months, and 18 Months ] [ Designated as safety issue: No ]
  • Impact of Alzheimer's Disease on Caregiver Questionnaire (IADCQ) [ Time Frame: Baseline, 6 Months, 9 Months, 12 Months, and 18 Months ] [ Designated as safety issue: No ]
  • Number (percentage) of participants experiencing related adverse events (AEs) and/or serious adverse events (SAEs) [ Time Frame: Throughout the study period, 18 Months ] [ Designated as safety issue: Yes ]
  • Number (percentage) of participants experiencing any AEs and/or SAEs [ Time Frame: Throughout the study period, 18 Months ] [ Designated as safety issue: Yes ]
  • Number (percentage) of infusions temporally associated with AEs and/or SAEs [ Time Frame: During or within 72 hours of completion of an infusion ] [ Designated as safety issue: Yes ]
  • Number (percentage) of infusions associated with AEs and/or SAEs occurring during or within 7 days of completion of an infusion [ Time Frame: During or within 7 days of completion of an infusion ] [ Designated as safety issue: Yes ]
  • Number (percentage) of infusions causally associated with AEs and/or SAEs [ Time Frame: Throughout the study period, 18 Months ] [ Designated as safety issue: Yes ]
  • Number and proportion of infusions discontinued, slowed, or interrupted due to an AE [ Time Frame: Throughout infusions, approximately 2-5 hours ] [ Designated as safety issue: Yes ]

Enrollment: 530
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGIV, 10% at Dose A (high dose) Biological: Immune Globulin Intravenous (Human), 10% Solution
Intravenous infusion every 2 weeks over 18 months
Other Name: IGIV, 10%
Experimental: IGIV, 10% at Dose B (low dose) Biological: Immune Globulin Intravenous (Human), 10% Solution
Intravenous infusion every 2 weeks over 18 months
Other Name: IGIV, 10%
Placebo Comparator: Placebo control Biological: Human albumin 0.25%
Intravenous infusion every 2 weeks over 18 months

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent - subject (or the subject'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 screening
  • Neuroimaging performed after symptom onset consistent with AD diagnosis
  • On stable doses of AD medication(s) for at least 12 weeks 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:

  • Possible AD or non-AD dementia
  • Current residence in a skilled nursing facility
  • Contraindication to undergoing MRI (eg pacemaker, severe claustrophobia, ferromagnetic implants such as a metal plate)
  • Clinically significant cardiovascular problems (e.g. uncontrolled blood pressure, heart disease, clotting disorders, strokes, atrial fibrillation, unstable angina (angina at rest) or recent heart attack)
  • Clinically significant congestive heart failure (e.g. New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II)
  • History of thrombosis and/or thromboembolic disease (central or peripheral) within the 12 months prior to screening
  • Specific findings on brain MRI (microhemorrhages, superficial siderosis, 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
  • Active autoimmune or neuro-immunologic disorder
  • 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 immunoglobulin and/or immunomodulatory therapies
  • Recent use of investigational drugs or biologics, including those aimed at altering AD progression
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524887

  Show 70 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Kathy Tobias, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01524887     History of Changes
Other Study ID Numbers: 161003, 2011-000914-21
Study First Received: January 20, 2012
Last Updated: May 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Australia: Department of Health and Ageing Therapeutic Goods Administration
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pharmaceutical Solutions
Albunex
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on August 21, 2014