AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

March 12, 2012 updated by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Cleo Roberts Center for Clinical Research / Sun Health Research Institute
    • California
      • Irvine, California, United States, 92697
        • UC Irvine
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Northridge, California, United States, 91324
        • Pharmacology Research Institute
      • San Diego, California, United States
        • UCSD Shiley-Marcos Alzheimer's Disease Research Center
      • San Francisco, California, United States
        • Memory & Aging Center, UCSF
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research, Inc.
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Department of Neurology
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian St. Luke's Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Department of Neurology - Indiana University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Behavioral Neurology
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System, Department of Neurology
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • The Memory Enhancement Center
    • New York
      • New York City, New York, United States, 10032
        • Sergievsky Center, Columbia University
      • Rochester, New York, United States, 14620
        • University of Rochester / Monroe Community Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Department of Psychiatry and Behavioral Sciences
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Memory and Aging Program, Butler Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Clinical Neuroscience Research Associates, Inc.
    • Washington
      • Seattle, Washington, United States, 98108
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to 85 years
  • Rosen Modified Hachinski Ischemic score less than or equal to 4
  • Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Fluency in English
  • Stable doses of medications

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure
  • Weight greater than 120 kg (264 lbs.)
  • History of autoimmune disease
  • Smoking more than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment with experimental immunotherapeutics or vaccines for AD
  • Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.15 mg/kg active bapineuzumab
Drug: bapineuzumab
IV, Q13w
Other Names:
  • AAB-001
Placebo Comparator: 0.15 mg/kg placebo
Other: placebo
IV Q13w
Experimental: 0.5 mg/kg active bapineuzumab
Drug: bapineuzumab
IV, Q13w
Other Names:
  • AAB-001
Placebo Comparator: 0.5 mg/kg placebo
Other: placebo
IV Q13w
Experimental: 1.0 mg/kg active bapineuzumab
Drug: bapineuzumab
IV, Q13w
Other Names:
  • AAB-001
Placebo Comparator: 1.0 mg/kg placebo
Other: placebo
IV Q13w
Experimental: 2.0 mg/kg active bapineuzumab
Drug: bapineuzumab
IV, Q13w
Other Names:
  • AAB-001
Placebo Comparator: 2.0 mg/kg placebo
Other: placebo
IV Q13w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety assessments
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
blood levels of administered study drug
Time Frame: 18 months
18 months
cognitive and functional assessments
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 27, 2005

First Submitted That Met QC Criteria

May 27, 2005

First Posted (Estimate)

May 30, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAB-001-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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