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

Sponsor:	Baxter Healthcare Corporation
Collaborator:	Alzheimer´s Disease Cooperative Study (ADCS)
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00818662

Purpose

The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 9 and 18 months, results in a significantly slower rate of decline of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.

Condition	Intervention	Phase
Alzheimer´s Disease	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Other: Placebo solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Cognition and global function [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognition and global function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Activities of daily living, behavior, and quality of life [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	December 2008
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Immune Globulin Intravenous (Human), 10% (IGIV, 10%)	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg bodyweight every 2 weeks for 70 weeks
Group 2: Experimental Immune Globulin Intravenous (Human), 10% (IGIV, 10%)	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg bodyweight every 2 weeks for 70 weeks
Group 3: Placebo Comparator	Other: Placebo solution 4 or 2 mL/kg bodyweight every 2 weeks for 70 weeks

Detailed Description:

Study visits: Each subject 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 subject must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

Eligibility

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

Criteria

Inclusion Criteria:

Written informed consent - subject (or 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 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 FDA 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 (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

There are other reasons why it might not be appropriate to pariticipate in this trial. Please consult an investigator at one of the trial sites for details.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818662

Show 35 Study Locations

Sponsors and Collaborators

Baxter Healthcare Corporation

Alzheimer´s Disease Cooperative Study (ADCS)

Investigators

Study Director:

Norman Relkin, MD, PhD

Alzheimer´s Disease Cooperative Study (ADCS)

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation ( Richard Schiff, MD, PhD; Medical Director )
Study ID Numbers:	160701
Study First Received:	January 7, 2009
Last Updated:	January 25, 2010
ClinicalTrials.gov Identifier:	NCT00818662 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:

Alzheimer´s
Dementia
Dementia of Alzheimer Type
Immunoglobulins
Gammaglobulins

IVIG
Antibodies
Amyloid
Dementia
Immunotherapy

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions

Antibodies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Dementia
Tauopathies
Immunoglobulins

ClinicalTrials.gov processed this record on February 08, 2010