Clincosm LogoSign in Get a demo

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

Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00112073
Collaborator
Pfizer (Industry)
234
Enrollment
26
Locations
8
Arms
44
Duration (Months)
9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0.15 mg/kg active bapineuzumab

Drug: bapineuzumab
IV, Q13w
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • AAB-001

    		•
    Placebo Comparator: 2.0 mg/kg placebo

    Other: placebo
    IV Q13w

    Outcome Measures

    Primary Outcome Measures

    1. safety assessments [18 months]

    Secondary Outcome Measures

    1. blood levels of administered study drug [18 months]

    2. cognitive and functional assessments [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cleo Roberts Center for Clinical Research / Sun Health Research Institute Sun City Arizona United States 85351
    2 UC Irvine Irvine California United States 92697
    3 Pharmacology Research Institute Los Alamitos California United States 90720
    4 Pharmacology Research Institute Northridge California United States 91324
    5 UCSD Shiley-Marcos Alzheimer's Disease Research Center San Diego California United States
    6 Memory & Aging Center, UCSF San Francisco California United States
    7 Yale University School of Medicine New Haven Connecticut United States 06510
    8 Georgetown University Medical Center Washington District of Columbia United States 20057
    9 Brain Matters Research, Inc. Delray Beach Florida United States 33445
    10 Mayo Clinic - Department of Neurology Jacksonville Florida United States 32224
    11 Rush Presbyterian St. Luke's Medical Center Chicago Illinois United States 60612
    12 Department of Neurology - Indiana University Medical Center Indianapolis Indiana United States 46202
    13 Behavioral Neurology Boston Massachusetts United States 02115
    14 University of Michigan Health System, Department of Neurology Ann Arbor Michigan United States 48109
    15 Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center Rochester Minnesota United States 55905
    16 The Memory Enhancement Center Long Branch New Jersey United States 07740
    17 Sergievsky Center, Columbia University New York City New York United States 10032
    18 University of Rochester / Monroe Community Hospital Rochester New York United States 14620
    19 Department of Psychiatry and Behavioral Sciences Durham North Carolina United States 27710
    20 Oregon Health and Science University Portland Oregon United States 97239
    21 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    22 Memory and Aging Program, Butler Hospital Providence Rhode Island United States 02906
    23 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    24 Baylor College of Medicine Houston Texas United States 77030
    25 Clinical Neuroscience Research Associates, Inc. Bennington Vermont United States 05201
    26 University of Washington Seattle Washington United States 98108

    Sponsors and Collaborators

    • JANSSEN Alzheimer Immunotherapy Research & Development, LLC
    • Pfizer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JANSSEN Alzheimer Immunotherapy Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT00112073
    Other Study ID Numbers:
    • AAB-001-201
    First Posted:
    May 30, 2005
    Last Update Posted:
    Mar 14, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC
    Alzheimer's disease
    immunotherapy
    beta amyloid
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Mar 14, 2012