Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

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:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
First received: June 4, 2009
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.


Condition Intervention Phase
Alzheimer Disease
Drug: bapineuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Multiple Dose, Parallel Group Investigation Of The Long-Term Safety, Tolerability, Reactogenicity And Efficacy Of Bapineuzumab Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety endpoints, including brain MRI [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5 mg/week
Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer disease
  • Completed preceding double-blind study (3133L1-2203 US)
  • MMSE score > 9.

Exclusion Criteria:

  • Significant brain MRI abnormalities
  • Clinically important psychiatric symptoms
  • History of stroke
  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: NCT00916617

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660
United States, Florida
Pfizer Investigational Site
Delray Beach, Florida, United States, 33445
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30046
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14620
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75214
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705
Pfizer Investigational Site
Maidson, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00916617     History of Changes
Other Study ID Numbers: 3133L1-2204, B2521009
Study First Received: June 4, 2009
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open-label
safety
antibody

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 September 16, 2014