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

This study has been terminated.
(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 24, 2008
Last updated: January 8, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Alzheimer Disease
Drug: bapineuzumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-Carriers

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Disability Assessment for Dementia total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain Amyloid Burden [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • CSF Phospho-tau level [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • MRI Brain Boundry Shift Integral [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • Divergence of effect [ Time Frame: 39 Weeks ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Dependence Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Responders [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating Sum of Boxes [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]

Enrollment: 835
Study Start Date: May 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bapineuzumab 0.5 mg/kg Drug: bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Other Name: AAB-001
Experimental: Bapineuzumab 1.0 mg/kg Drug: bapineuzumab
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Other Name: AAB-001
Placebo Comparator: Placebo Drug: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.


Ages Eligible for Study:   50 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00667810

  Show 260 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00667810     History of Changes
Obsolete Identifiers: NCT00909623
Other Study ID Numbers: 3133K1-3000, B2521001
Study First Received: April 24, 2008
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 25, 2015