Study Evaluating the Safety and Efficacy 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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00676143
First received: May 2, 2008
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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 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 Boundary 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: 1099
Study Start Date: May 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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
Placebo Comparator: Placebo Drug: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of probable AD, with MMSE score of 16-26, and brain 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, or a major psychiatric disorder
  • Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
  • Woman 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 ClinicalTrials.gov identifier: NCT00676143

  Show 227 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676143     History of Changes
Obsolete Identifiers: NCT00909675
Other Study ID Numbers: 3133K1-3001, B2521002
Study First Received: May 2, 2008
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
antibody
immunotherapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014