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

May 2, 2008
December 20, 2012
May 2008
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Alzheimer's Disease Assessment Scale-Cognitive Subscale; Disability Assessment for Dementia [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00676143 on ClinicalTrials.gov Archive Site
  • 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 ]
Neuropsychological Test Battery; Clinical Demential Rating Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: bapineuzumab
    Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
    Other Name: AAB-001
  • Drug: placebo
    Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
  • Experimental: Bapineuzumab 0.5 mg/kg
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1099
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Chile,   Croatia,   Finland,   France,   Germany,   Italy,   Japan,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00676143
3133K1-3001, B2521002
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP