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 (Responsible Party):	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 18 months, slows the rate or prevents the progression 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 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 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:

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Rhophylac Rho(D) Immune Globulin

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Cognition and global function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Measured by the cognitive subscale of the Alzheime´s Disease Assessment Scale (ADAS-Cog) and the Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL)

Secondary Outcome Measures:

Cognition and global function [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Measured by ADAS-Cog and ADCS-ADL

Enrollment:	390
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 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 Other Name: Gammagard Liquid
Experimental: Group 2 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 Other Name: Gammagard Liquid
Placebo Comparator: Group 3	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 44 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)
Study Director:	David Gelmont, MD	Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00818662 History of Changes
Other Study ID Numbers:	160701
Study First Received:	January 7, 2009
Last Updated:	November 28, 2011
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
Immunotherapy

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012