We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00575055
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Bapineuzumab 0.5 mg/kg Drug: Placebo Control Drug: Bapineuzumab 1.0 m/kg Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.
Study Start Date : December 2007
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
Drug: Bapineuzumab 0.5 mg/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Name: AAB-001
Placebo Comparator: Placebo Dose
infusion every 13 weeks for a total of 6 infusions.
Drug: Placebo Control
given by infusion every 13 weeks for a total of 6 infusions.
Experimental: Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions.
Drug: Bapineuzumab 1.0 m/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Name: AAB-001


Outcome Measures

Primary Outcome Measures :
  1. Cognitive and Functional [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Cognitive and Global [ Time Frame: 18 months ]
  2. Imaging and biochemical biomarkers of disease status [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 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

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575055


  Show 186 Study Locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00575055     History of Changes
Other Study ID Numbers: ELN115727-302
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders