A Long-Term Safety And Tolerability Extension Study 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:
NCT00998764
First received: October 16, 2009
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.


Condition Intervention Phase
Alzheimer Disease
Drug: Bapineuzumab 0.5 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Extension, Multicenter, Long-term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Carriers And Participated In Study 3133K1-3001.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of treatment emergent adverse events, clinically important changes in vital signs, weight, ECG, laboratory determinations, brain magnetic resonance imaging (MRI), physical and neurological examinations and infusion site assessments [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale; Disability Assessment for Dementia, Neuropsychiatric Inventory [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 493
Study Start Date: December 2009
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 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Name: AAB-001

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
  • Mini-Mental Status Examination (MMSE) >=10 at screening
  • Caregiver able to attend all clinic visits with subject

Exclusion Criteria:

  • Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
  • Any significant brain MRI abnormality.
  • Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
  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: NCT00998764

  Show 141 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: NCT00998764     History of Changes
Other Study ID Numbers: 3133K1-3003, B2521004
Study First Received: October 16, 2009
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
antibody
immunotherapy

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

ClinicalTrials.gov processed this record on October 20, 2014