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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2012

Last Updated Date

May 19, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Cognitive subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) inventory [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01524887 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

ADCS-Clinical Global Impression of Change (CGIC) [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory (NPI) [ Time Frame: 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 3 IGIV, 10% in Alzheimer´s Disease

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer´s Disease

Intervention ^ICMJE

Biological: Immune Globulin Intravenous (Human), 10% Solution
Intravenous infusion every 2 weeks over 18 months

Other Name: IGIV, 10%
Biological: Human albumin 0.25%
Intravenous infusion every 2 weeks over 18 months

Study Arm (s)

Experimental: IGIV, 10% at Dose A (high dose)
Intervention: Biological: Immune Globulin Intravenous (Human), 10% Solution
Experimental: IGIV, 10% at Dose B (low dose)
Intervention: Biological: Immune Globulin Intravenous (Human), 10% Solution
Placebo Comparator: Placebo control
Intervention: Biological: Human albumin 0.25%

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

530

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 89 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Japan, Poland, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01524887

Other Study ID Numbers ^ICMJE

161003, 2011-000914-21

Has Data Monitoring Committee

Yes

Responsible Party

Baxter Healthcare Corporation

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kathy Tobias, MD

Baxter Healthcare Corporation

Information Provided By

Baxter Healthcare Corporation

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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