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Study Evaluating The Efficacy...

Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

Last Updated: 2016-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

901 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-08-31

Brief Summary

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This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bapineuzumab 0.5 mg/kg

Group Type EXPERIMENTAL

bapineuzumab

Intervention Type DRUG

Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

Bapineuzumab 1.0 mg/kg

Group Type EXPERIMENTAL

bapineuzumab

Intervention Type DRUG

Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Interventions

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bapineuzumab

Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

Intervention Type DRUG

bapineuzumab

Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

Intervention Type DRUG

placebo

Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Intervention Type DRUG

Other Intervention Names

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AAB-001 AAB-001

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
* Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria

* Significant neurological disease other than AD
* Major psychiatric disorder
* Contraindication to undergo brain MRI \[e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body\]
* Women of childbearing potential

Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status

Dedicated Clinical Research

Goodyear, Arizona, United States

Site Status

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Jeffrey S. Gitt, DO, PC

Phoenix, Arizona, United States

Site Status

The Compounding Center (IP Mixing Only)

Phoenix, Arizona, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

Clinical Trials, Inc.

Little Rock, Arkansas, United States

Site Status

ATP Clinical Research, Incorporated

Costa Mesa, California, United States

Site Status

Pharmacology Research Institute

Encino, California, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

Infusion Care Pharmacey

Laguna Hills, California, United States

Site Status

Senior Clinical Trials, Incorporated

Laguna Hills, California, United States

Site Status

Faculty Physicians and Surgeons of Loma Linda University School of Medicine

Loma Linda, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Long Beach, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Coordinated Clinical Research

San Diego, California, United States

Site Status

LabCorp

San Diego, California, United States

Site Status

Sharp and Children's MRI Center, LLC

San Diego, California, United States

Site Status

Sharp Infusion Therapy Center

San Diego, California, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Sharp Mesa Vista Hospital

San Diego, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

Alpine Clinical Research Center, Inc.

Boulder, Colorado, United States

Site Status

Associated Neurologists, PC

Boulder, Colorado, United States

Site Status

The Mile High Research Center

Denver, Colorado, United States

Site Status

Associated Neurologists, PC

Danbury, Connecticut, United States

Site Status

Associated Neurologists of Southern Connecticut, P.C.

Fairfield, Connecticut, United States

Site Status

Bendheim Cancer Center

Greenwich, Connecticut, United States

Site Status