Text Size

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00574132
First received: December 10, 2007
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Bapineuzumab
Drug: Placebo Control
 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 (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Imaging and biochemical biomarkers of disease status [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 1331
Study Start Date: December 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bapineuzumab Dose A Drug: Bapineuzumab
Comparisons of 2 different doses of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.
Placebo Comparator: Placebo Dose Drug: Placebo Control
Comparisons of 2 different doses of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.
Experimental: Bapineuzumab Dose B Drug: Bapineuzumab
Comparisons of 2 different doses of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.

  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
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574132

  Show 251 Study Locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00574132     History of Changes
Other Study ID Numbers: ELN115727-301
Study First Received: December 10, 2007
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Austrian Agency for Health and Food Safety (AGES)
Germany: Paul-Ehrlich-Institut (PEI)

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 June 17, 2013