Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease

Last updated: April 21, 2014
Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT01254773
AAB-001-SC-ALZ-2003
  • Ages 50-89
  • All Genders

Study Summary

This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of probable AD

  • Age from 50 to less than 89

  • Mini-Mental Status Exam score of 18-26 inclusive

  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD

  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)

  • Caregiver able to attend all clinic visits with patient

  • Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion

Exclusion Criteria:

  • Significant neurological disease other than AD

  • Major psychiatric disorder

  • Significant systemic illness

  • History of stroke or seizure, autoimmune disease, myocardial infarction within thelast 2 years

  • Smoking greater than 20 cigarettes per day

  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications

  • Prior treatment experimental immunotherapeutics or vaccines for AD

  • Women of childbearing potential

  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Study Design

Total Participants: 146
Study Start date:
December 01, 2010
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Janssen AI Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Janssen AI Investigational Site

    La Habra, California 90631
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Lomita, California 90277
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Pasadena, California 91105
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Fort Meyers, Florida 33919
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Janssen AI Investigational Site

    South Miami, Florida 33143
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Janssen AI Investigational Site

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Latham, New York 12210
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Janssen AI Investigational Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

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