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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-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: NCT00574132
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Study Description
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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 230 study sites in the US and Canada and up to 35 sites outside of North America 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1331 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 Non- Carriers.
Study Start Date : December 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
infusion every 13 weeks for a total of 6 infusions
Other Name: AAB-001
Placebo Comparator: Placebo Control
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
infusion every 13 weeks for a total of 6 infusions
Other Name: AAB-001


Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 88 Years   (Adult, Older Adult)
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
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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): NCT00574132


Locations
Show Show 251 study locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00574132    
Other Study ID Numbers: ELN115727-301
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders