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

Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00574132
Collaborator
Pfizer (Industry)
1,331
251
3
54
5.3
0.1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Bapineuzumab 0.5 mg/kg
  • Drug: Placebo Control
  • Drug: Bapineuzumab 1.0 m/kg
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1331 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bapineuzumab 0.5 mg/kg

infusion every 13 weeks for a total of 6 infusions

Drug: Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
Other Names:
  • AAB-001
  • Placebo Comparator: Placebo Control

    infusion every 13 weeks for a total of 6 infusions.

    Drug: Placebo Control
    given by infusion every 13 weeks for a total of 6 infusions.

    Experimental: Bapineuzumab 1.0 m/kg

    infusion every 13 weeks for a total of 6 infusions.

    Drug: Bapineuzumab 1.0 m/kg
    infusion every 13 weeks for a total of 6 infusions
    Other Names:
  • AAB-001
  • Outcome Measures

    Primary Outcome Measures

    1. Cognitive and Functional [18 months]

    Secondary Outcome Measures

    1. Cognitive and Global [18 months]

    2. Imaging and biochemical biomarkers of disease status [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 88 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Hospital (UAB) Birmingham Alabama United States 35205
    2 Dedicated Clinical Research, Inc. Goodyear Arizona United States 85395
    3 Banner Alzheimer's Institute Phoenix Arizona United States 85006
    4 HOPE Research Institute, LLC Phoenix Arizona United States 85050
    5 Banner Research Institute Sun City Arizona United States 85351
    6 University of Arizona College of Medicine, Health Science Center Tucson Arizona United States 85724-5023
    7 Northwest Neurospecialists, PLLC Tucson Arizona United States 85741
    8 Clinical Trials Inc. Little Rock Arkansas United States 72205
    9 East Bay Physicians Medical Group Berkeley California United States 94705
    10 AVI Clinical Research Carson California United States 90746
    11 ATP Clinical Research, Inc Costa Mesa California United States 92626
    12 Pharmacology Research Institute Encino California United States 91316
    13 Margolin Brain Institute Fresno California United States 93720
    14 Neurology Center of North Orange County Fullerton California United States 92835
    15 Integrated Medical and Behavioral Associates Glendale California United States 91204
    16 Sun Valley Behavioral Medical Center Imperial California United States 92251
    17 Coordinated Clinical Research La Jolla California United States 92037
    18 University of California San Diego/Shela Marcos Alzheimer's Disease Research Center La Jolla California United States 92037
    19 Senior Clinical Trials Laguna Hills California United States 92653
    20 Collaborative Neuroscience Network Long Beach California United States 90806
    21 Pharmacology Research Institute Los Alamitos California United States 90720
    22 Vintage Institute for Clinical Research, Inc Los Angeles California United States 90035
    23 UCLA Department of Neurology Los Angeles California United States 90095
    24 Synergy Research National City California United States 91950
    25 Pharmacology Research Institute Newport Beach California United States 92660
    26 The Neurology Center Oceanside California United States 92056
    27 University of California, Irvine Medical Center Orange California United States 92868
    28 Neuro-Therapeutics Inc. Pasadena California United States 91105
    29 The Southwest Institute for Clinical Research, Inc. Rancho Mirage California United States 92270
    30 Sutter Neuroscience Medical Group Sacramento California United States 95816
    31 University of California, Davis, Alzheimer's Disease Center Sacramento California United States 95817
    32 Artemis Institute for Clinical Research San Diego California United States 92123
    33 Sharp Mesa Vista Hospital San Diego California United States 92123
    34 San Francisco Clinical Research Center San Francisco California United States 94109
    35 University of California, San Francisco San Francisco California United States 94117
    36 Neuropsychiatric Research Center of Orange County Santa Ana California United States 92701
    37 Neurological Research Institute Santa Monica California United States 90404
    38 Schuster Medical Research Institute Sherman Oaks California United States 91403
    39 Diablo Clinical Research, Inc Walnut Creek California United States 94598
    40 Alpine Clinical Research Center Boulder Colorado United States 80304
    41 Mile High Research Center Denver Colorado United States 80218
    42 Advanced Neurosciences Research, LLC Fort Collins Colorado United States 80528
    43 Associated Neurologists, PC Danbury Connecticut United States 06810
    44 Associated Neurologists of Southern CT, P.C. Fairfield Connecticut United States 06824
    45 Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510
    46 Yale University School of Medicine, Alzheimer's Disease Research Unit New Haven Connecticut United States 06510
    47 Research Center for Clinical Studies, Inc Norwalk Connecticut United States 06851
    48 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    49 Christiana Care Health Services Newark Delaware United States 19713
    50 Georgetown University Medical Center Washington District of Columbia United States 20057
    51 JEM Research, LLC Atlantis Florida United States 33462
    52 Bradenton Research Center, Inc Bradenton Florida United States 34205
    53 Quantum Laboratories, Inc. Deerfield Beach Florida United States 33064
    54 Brain Matters Research, Inc. Delray Beach Florida United States 33445
    55 Neurologic Consultants, P.A. Fort Lauderdale Florida United States 33308
    56 Clinical Physiology Associates, Inc. Fort Myers Florida United States 33916
    57 Emerald Coast Mood & Memory, PA. Fort Walton Beach Florida United States 32547
    58 Neuropsychiatric Research Center of Southwest Florida Ft. Myers Florida United States 33912
    59 MD Clinical Hallandale Beach Florida United States 33009
    60 Sunrise Clinical Research, Inc. Hollywood Florida United States 33021
    61 Mayo Clinic College of Medicine Jacksonville Florida United States 32224
    62 Neurology Associates Maitland Florida United States 32751
    63 Melbourne International Medicine Associates, MIMA Melbourne Florida United States 32901
    64 Pharmax Research Clinic, LLC Miami Florida United States 33126
    65 Miami Jewish Health Systems Miami Florida United States 33137
    66 Allied Clinical Trials, Inc. Miami Florida United States 33156
    67 Renstar Medical Research Ocala Florida United States 34471
    68 Medical Research Group of Central Florida Orange City Florida United States 32763
    69 Compass Research, LLC Orlando Florida United States 32806
    70 Palm Beach Neurological Center/Advanced Research Consultants Palm Beach Gardens Florida United States 33418
    71 Broward Research Group, Inc. Pembroke Pines Florida United States 33026
    72 Neurostudies, Inc Port Charlotte Florida United States 33952
    73 Roskamp Institute Sarasota Florida United States 34243
    74 Miami Research Associates South Miami Florida United States 33143
    75 Suncoast Neuroscience Associates, Inc. St Petersburg Florida United States 33713
    76 Meridien Research St. Petersburg Florida United States 33709
    77 Axiom Clinical Research of Florida Tampa Florida United States 33609
    78 Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute Tampa Florida United States 33613
    79 Stedman Clinical Trials Tampa Florida United States 33613
    80 University of South Florida Suncoast Alzheimer's and Gerontology Center Tampa Florida United States 33613
    81 Premiere Research Institute West Palm Beach Florida United States 33407
    82 Emory University/School of Medicine Atlanta Georgia United States 30322
    83 MS Center of Atlanta Atlanta Georgia United States 30327
    84 NeuroTrials Research, Inc. Atlanta Georgia United States 30342
    85 Medical Research and Health Education Foundation, Inc. Columbus Georgia United States 31909
    86 Dekalb Neurology Associates Decatur Georgia United States 30033
    87 Gwinnett Medical Center Lawrenceville Georgia United States 30045
    88 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    89 University of Chicago Medical Center Chicago Illinois United States 60637
    90 Alexian Brothers Neurosciences Institute Elk Grove Village Illinois United States 60007
    91 Methodist Medical Center of Illinois Peoria Illinois United States 61602
    92 Southern Illinois University, School of Medicine Springfield Illinois United States 62794-9643
    93 Elkhart Clinic, LLC Elkhart Indiana United States 46514
    94 Fort Wayne Neurological Center Fort Wayne Indiana United States 46805
    95 Indiana University School of Medicine Indianapolis Indiana United States 46202
    96 Kansas Multi-Specialist Group Kansas City Kansas United States 66112
    97 University of Kansas Medical Center Kansas City Kansas United States 66160
    98 Mid America Neuroscience Institute Lenexa Kansas United States 66214
    99 Associates in Neurology, PSC Lexington Kentucky United States 40513
    100 University of Kentucky Lexington Kentucky United States 40536
    101 Four Rivers Clinical Research Paducah Kentucky United States 42003
    102 Lake Charles Clinical Trials Lake Charles Louisiana United States 70629
    103 Louisiana Research Associates, Inc. New Orleans Louisiana United States 70114
    104 Louisana State University Health Sciences Center Shreveport Louisiana United States 70112
    105 J. Gary Booker, MD, APMC Shreveport Louisiana United States 71104
    106 Maine Medical Partners Neurology Scarborough Maine United States 04074
    107 University of Maryland Baltimore Maryland United States 21201
    108 Johns Hopkins School of Medicine Baltimore Maryland United States 21224
    109 CBH Health, LLC Rockville Maryland United States 20850
    110 McLean Hospital Belmont Massachusetts United States 02478
    111 Brigham and Women's Hospital Boston Massachusetts United States 02115
    112 Boston University School of Medicine Boston Massachusetts United States 02118
    113 ActivMed Practices and Research, Inc Haverhill Massachusetts United States 01830
    114 Neurocare, Inc. Newton Massachusetts United States 02459
    115 Neuroscience Research of the Berkshires Pittsfield Massachusetts United States 01201
    116 Donald S. Marks, MD, P.C. Plymouth Massachusetts United States 02360
    117 Memory Wellness Clinic Springfield Massachusetts United States 01104
    118 Springfield Neurology Associates Springfield Massachusetts United States 01104
    119 Coastal Research Associates, Inc. Weymouth Massachusetts United States 02190
    120 University of Michigan Ann Arbor Michigan United States 48105
    121 Henry Ford Hospital Detroit Michigan United States 48202
    122 Michigan State University East Lansing Michigan United States 48824
    123 Saint Mary's Health Care Grand Rapids Michigan United States 49503
    124 Borgess Medical Center/Borgess Research Institute Kalamazoo Michigan United States 49048
    125 Mayo Clinic Rochester Minnesota United States 55905
    126 Precise Research Centers Flowood Mississippi United States 39232
    127 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    128 Saint Luke's Hospital, Mid America Brain and Stroke Institute Kansas City Missouri United States 64111
    129 The Center for Pharmaceutical Research Kansas City Missouri United States 64114
    130 St. Louis University School of Medicine St. Louis Missouri United States 63104
    131 Washington University School of Medicine St. Louis Missouri United States 63108
    132 Deaconess Billings Clinical Research Center Billings Montana United States 59101
    133 Advanced Neurology Specialists Great Falls Montana United States 59405
    134 University of Nebraska Medical Center Omaha Nebraska United States 68198
    135 Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada United States 89106
    136 Coastal Neurology, PA Dover New Hampshire United States 03820
    137 Dartmouth Hitchcock Medical Center, Dept of Neurology Lebanon New Hampshire United States 03756
    138 Comprehensive Clinical Research Berlin New Jersey United States 08009
    139 The Memory Enhancement Center of America, Inc. Eatontown New Jersey United States 07724
    140 Alzheimer's Research Corporation (ARC) Manchester New Jersey United States 08759
    141 The NeuroCognitive Institute Mount Arlington New Jersey United States 07856
    142 Princeton Medical Institute Princeton New Jersey United States 08540
    143 University of Medicine and Dentistry of New Jersey Stratford New Jersey United States 08084
    144 Shore Neurology, P.A. Toms River New Jersey United States 08755
    145 Albuquerque Neuroscience, Inc. Albuquerque New Mexico United States 87109
    146 University of New Mexico, Health Sciences Center Albuquerque New Mexico United States 87131
    147 Upstate Clinical Research, LLC Albany New York United States 12205
    148 Neurological Associates of Albany, P.C. Albany New York United States 12208
    149 Neuroscience Research Center at Albany Medical Center Albany New York United States 12208
    150 Social Psychiatry Research Institute Brooklyn New York United States 11235
    151 Five Towns Neuroscience Research Cedarhurst New York United States 11516
    152 Advanced Bio-Behavioral Sciences Elmsford New York United States 10523
    153 Empire Neurology, PC Latham New York United States 12110
    154 Neurological Care of CNY Liverpool New York United States 13088
    155 Parker Jewish Institute for Health Care & Rehabilitation New Hyde Park New York United States 11040
    156 NYU School of Medicine/Psychiatry New York New York United States 10016
    157 Mt. Sinai School of Medicine New York New York United States 10029
    158 Columbia University/Medical Center New York New York United States 10032
    159 Dent Neurologic Institute New York New York United States 14226
    160 Nathan S. Kline Institute for Psychiatric Research Orangeburg New York United States 10962
    161 University of Rochester Medical Center @ Monroe Community Hospital Rochester New York United States 14620
    162 Duke University Medical Center Durham North Carolina United States 27710
    163 Clinical Trials of America, Inc Hickory North Carolina United States 28601
    164 New Hope Clinical Research Hickory North Carolina United States 28601
    165 Raleigh Neurology Associates Raleigh North Carolina United States 27607
    166 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    167 Rakesh Ranjan, M.D. & Associates, Inc. Beachwood Ohio United States 44125
    168 Neuro-Behavioral Clinical Research, Inc Canton Ohio United States 44718
    169 NeuroCare Center, Inc Canton Ohio United States 44718
    170 University Memory and Aging Center University Hospitals of Cleveland/Case Medical Center Cleveland Ohio United States 44120
    171 Ohio State University Columbus Ohio United States 43210
    172 Neurology Specialists, Inc. Dayton Ohio United States 45417
    173 Neurology and Neuroscience Center of Ohio Toledo Ohio United States 43623
    174 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    175 Red River Medical Research Center, LLC Oklahoma City Oklahoma United States 73112
    176 Providence Medical Group-Medford Neurology Medford Oregon United States 97504
    177 Summit Research Group, Inc. Portland Oregon United States 97210
    178 Providence Health Service System, AD Center, Brain Institute Portland Oregon United States 97225
    179 Oregon Health & Sciences University Portland Oregon United States 97239
    180 Abington Neurological Associates, Ltd Abington Pennsylvania United States 19001
    181 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    182 The Clinical Trial Center, LLC Jenkintown Pennsylvania United States 19046
    183 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
    184 Penn Memory Center Philadelphia Pennsylvania United States 19104
    185 Jefferson Hospital for Neuroscience Philadelphia Pennsylvania United States 19107
    186 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    187 Clinical Trials Research Services, LLC Pittsburg Pennsylvania United States 15206
    188 Rhode Island Mood and Memory Research Institute East Providence Rhode Island United States 02914
    189 Rhode Island Hospital Providence Rhode Island United States 02903
    190 Butler Hospital Providence Rhode Island United States 02906
    191 Medical University of South Carolina N. Charleston South Carolina United States 29406
    192 Avera Research Institute Sioux Falls South Dakota United States 57105
    193 Neurology Clinic, PC Cordova Tennessee United States 38018
    194 Psychiatric Consultants, PC Franklin Tennessee United States 37067
    195 East Tennessee State University Johnson City Tennessee United States 37614-1707
    196 Volunteer Research Group Knoxville Tennessee United States 37920
    197 Senior Adults Specialty Research (SASR) Austin Texas United States 78757
    198 Texas Neurology, PA Dallas Texas United States 75214
    199 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390
    200 InSite Clinical Research DeSoto Texas United States 75115
    201 University of North Texas/Health Sciences Center-Fort Worth Fort Worth Texas United States 76106
    202 Claghorn-Lesem Research Clinic, Ltd. Houston Texas United States 77008
    203 Baylor College of Medicine Houston Texas United States 77030
    204 Innovative Clinical Trials San Antonio Texas United States 78229
    205 Integra Clinical Research, LLC San Antonio Texas United States 78231
    206 Grayline Clinical Drug Trials, Inc Wichita Falls Texas United States 76309
    207 Wasatch Clinical Research Salt Lake City Utah United States 84107
    208 University of Utah, Dept of Neurology Salt Lake City Utah United States 84108
    209 The Memory Clinic Bennington Vermont United States 05201
    210 Fletcher Allen Health Care Burlington Vermont United States 05401
    211 Innovative Clinical Research Center Alexandria Virginia United States 22304
    212 University of Virginia Charlottesville Virginia United States 22903
    213 Alliance Research Group, LLC Richmond Virginia United States 23230
    214 University of Washington Veterans Affairs Seattle Washington United States 98108
    215 Pacific Medical Centers Seattle Washington United States 98144
    216 Wenatchee Valley Medical Center Wenatchee Washington United States 98801
    217 University of Wisconson Medical School of Medicine and Public Health Madison Wisconsin United States 53705
    218 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    219 Independent Pyschiatric Consultants Waukesha Wisconsin United States 53188
    220 Medizinische Universität Graz Graz Styria Austria 8036
    221 Medizinische Universität Wien Wien Vienna Austria 1090
    222 University of Calgary, Foothills Medical Centre Calgary Alberta Canada T2N 4Z6
    223 Medical Arts Health Research Group Kamloops British Columbia Canada V2C 1K7
    224 Medical Arts Health Research Group Kelowna British Columbia Canada V1Y 3G8
    225 Medical Arts Health Research Group Penticton British Columbia Canada V2A 5C8
    226 University of British Columbia (UBC) Hospital Vancouver British Columbia Canada V5Z 3T7
    227 Hotel Dieu Hospital/Queens University Memorial Clinics Kingston Ontario Canada K7L 5G2
    228 Saint Joseph's Health Care London, Saint Joseph's Hospital London Ontario Canada N6A 4V2
    229 Parkwood Hospital London Ontario Canada N6C 5J1
    230 Bruyere Continuing Care Ottawa Ontario Canada K1N 5C8
    231 Kawartha Regional Memory Clinic Peterborough Ontario Canada K9H 2P4
    232 Neurology Research Inch./Toronto Memory Program Toronto Ontario Canada M3B 2S7
    233 Toronto Centre for Memory and Aging Toronto Ontario Canada M6M 3Z5
    234 Ontario Shores Centre for Mental Health Scienes Whitby Ontario Canada L1N 5S9
    235 Neuro Rive-Sud Memory Clinic Greenfield Park Quebec Canada J4V 2J2
    236 Hopital Maisonneuve-Rosemont, Comite d' ethique de la recherche Montreal Quebec Canada H1T 2M4
    237 Jewish General Hospital Montréal Quebec Canada H3T 1E2
    238 Diex Research Sherbrooke Inc. Sherbrooke Quebec Canada JIH 1Z1
    239 Douglas Mental Health University Institute Verdun Quebec Canada H4H 1R3
    240 Universitätsklinik Tübingen Tübingen Baden-wuerttemberg Germany 72076
    241 Universitätsklinik Ulm Ulm Baden-wuerttemberg Germany 89081
    242 Universitätsklinik Freiburg Freiburg Baden-Württemberg Germany 79106
    243 Universitätsklinikum Ulm Günzburg Bayern Germany 89312
    244 Ludwig-Maximilians-Universität München München Bayern Germany 80336
    245 Klinikum Rechts der Isar der Technischen Universität München München Bayern Germany 81675
    246 Universitätsklinikum Regensburg Regensburg Byern Germany 93053
    247 Saint Josefs Hospital Bochum Nordrhein-westfalen Germany 44791
    248 Universitätsklinikum des Saarlandes Homburg/Saar Saarland Germany 66421
    249 AFL Arzneimittelforschung Leipzig GmbH Leipzig Sachen Germany 04107
    250 ABX-CRO advanced pharmaceutical services Forschungsgesellschaft GmbH Dresden Saschen Germany 01307
    251 UKE Hamburg Hamburg Germany 20246

    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:
    NCT00574132
    Other Study ID Numbers:
    • ELN115727-301
    First Posted:
    Dec 17, 2007
    Last Update Posted:
    Nov 25, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 25, 2013