AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00112073
First received: May 27, 2005
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).


Condition Intervention Phase
Alzheimer's Disease
Drug: bapineuzumab
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • safety assessments [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • blood levels of administered study drug [ Time Frame: 18 months ]
  • cognitive and functional assessments [ Time Frame: 18 months ]

Enrollment: 234
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.15 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 0.15 mg/kg placebo Other: placebo
IV Q13w
Experimental: 0.5 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 0.5 mg/kg placebo Other: placebo
IV Q13w
Experimental: 1.0 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 1.0 mg/kg placebo Other: placebo
IV Q13w
Experimental: 2.0 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 2.0 mg/kg placebo Other: placebo
IV Q13w

Detailed Description:

The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to 85 years
  • Rosen Modified Hachinski Ischemic score less than or equal to 4
  • Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Fluency in English
  • Stable doses of medications

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure
  • Weight greater than 120 kg (264 lbs.)
  • History of autoimmune disease
  • Smoking more than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment with experimental immunotherapeutics or vaccines for AD
  • Presence of pacemakers or foreign metal objects in the eyes, skin, or body
  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: NCT00112073

  Hide Study Locations
Locations
United States, Arizona
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
UC Irvine
Irvine, California, United States, 92697
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Northridge, California, United States, 91324
UCSD Shiley-Marcos Alzheimer's Disease Research Center
San Diego, California, United States
Memory & Aging Center, UCSF
San Francisco, California, United States
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Mayo Clinic - Department of Neurology
Jacksonville, Florida, United States, 32224
United States, Illinois
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Behavioral Neurology
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System, Department of Neurology
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
The Memory Enhancement Center
Long Branch, New Jersey, United States, 07740
United States, New York
Sergievsky Center, Columbia University
New York City, New York, United States, 10032
University of Rochester / Monroe Community Hospital
Rochester, New York, United States, 14620
United States, North Carolina
Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States, 05201
United States, Washington
University of Washington
Seattle, Washington, United States, 98108
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00112073     History of Changes
Other Study ID Numbers: AAB-001-201
Study First Received: May 27, 2005
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Alzheimer's disease
immunotherapy
beta amyloid

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 18, 2014