Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: bapineuzumab; Drug: placebo; Drug: bapineuzumab

• Study Type: Interventional
• Enrollment (Actual): 901
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina, 1431
    • Cemic University Hospital
• Australia
  • Adelaide SA, Australia, 5000
    • Royal Adelaide Hospital
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Hornsby, New South Wales, Australia, 02077
      • Hornsby Kuringai Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3353
      • CDAMS Ballarat Base Hospital
    • West Heidelberg, Victoria, Australia, 3081
      • Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Hollywood Private Hospital
    • Nedlands, Western Australia, Australia, 6009
      • McCusker Alzheimer's Research Foundation Inc.
• Belgium
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim / Neurologie
  • Brugge, Belgium, 8000
    • Az. St. Jan Ruddershove 35
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, 3000
    • University Hospital Gathuisberg
  • Roeselare, Belgium, 8800
    • H.-Hartziekenhuis Roeselare-Menen
• Canada
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Ontario
    • North York, Ontario, Canada, M6M 3Z5
      • Centre for Memory and Aging
    • Ottawa, Ontario, Canada, K1N 5C8
      • Bruyere Continuing Care
    • Toronto, Ontario, Canada, M4N 3M5
      • SunnyBrook Health Sciences Centre
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
  • Quebec
    • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
      • Centre de Recherche ADAPRA Inc.
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H1T 2M4
      • Recherche Clinique de Neurologie
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Chile
  • Santiago, Chile, 7530193
    • Psicomedica Research Group
  • Santiago, Chile
    • Especialidades Medicas L&S
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb
  • Zagreb, Croatia, 10000
    • Sestre milosrdnice Zagreb
• Finland
  • Kuopio, Finland, FIN-70210
    • Itä-Suomen yliopisto
  • Turku, Finland, 20520
    • Turku University Hospital
• France
  • Amiens, France, 80054
    • CHU Hôpital Nord
  • Bron, France, 69677
    • Hôpital Neurologique
  • Caen, France, 14033
    • CHU de Caen
  • Colmar, France, 68024
    • Hopitaux Civils de Colmar
  • Dijon, France, 21000
    • CHU de Dijon
  • Lille, France, 59037
    • Hopital Roger Salengro
  • Marseille, France, 13009
    • Hôpital Sainte Marguerite
  • Marseille, France, 13885
    • Hôpital La Timone
  • Montpellier, France, 34295
    • CHU Hôpital Gui de Chaulliac
  • Nantes - Saint Herblain, France, 44093
    • CHU Nord - Hôpital Guillaume et René Laënnec
  • Nice, France, 06000
    • Hôpital Cimiez
  • Paris, France, 75013
    • Groupe Hospitalier Broca-La Rochefoucauld
  • Paris Cedex 13, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Poitiers, France, 86021
    • CHU La Milétrie
  • Reims, France, 51000
    • C.H.U de Reims
  • Rouen, France, 76031
    • Chu - Hôpital Charles Nicolle
  • Toulouse, France, 31059
    • Hôpital Purpan
  • Toulouse, France, 31300
    • CHU Purpan - Hôpital Casselardit
  • Cedex
    • Rennes, Cedex, France, 35064
      • CHRU Hôtel Dieu
• Germany
  • Berlin, Germany, 14050
    • Klinik für Psychiatrie und Psychotherapie
  • Bochum, Germany, 44791
    • St. Josef-Klinikum
  • Offenburg, Germany, 77654
    • Ortenau Klinikum
  • Regensburg, Germany, 93053
    • Universitaet Regensburg
• Italy
  • Ancona, Italy, 60020
    • Università Politecnica delle Marche
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Catania, Italy, 95126
    • Unita' Operativa Complessa di Neurologia
  • Chieti, Italy, 66013
    • CeSI (Centro di Scienze dell'invecchiamento) -
  • Firenze, Italy, 50131
    • Università degli studi di Firenze
  • Milano, Italy, 20133
    • Fondazione IRCCS- Istituto Neurologico Carlo Besta
  • Milano, Italy, 20132
    • Ospedale S. Raffaele
  • Milano, Italy, 20127
    • Ospedale S. Raffaele
  • Monza, Italy, 20052
    • Ospedale S. Gerardo
  • Monza, Italy, 20052
    • Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
  • Roma, Italy, 00179
    • Unita' Operativa C - Riabilitazione Neurologica
  • Roma, Italy, 00128
    • Clinica Neurologica
  • Siena, Italy, 53100
    • Università degli Studi di Siena
• Japan
  • Aichi, Japan, 446-8510
    • Yachiyo Hospital
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chiba-East Hospital
  • Chiba, Japan, 260-8656
    • Kashiwado Hospital
  • Chiba, Japan, 270-1694
    • Nippon Medical School Chiba Hokusoh Hospital
  • Fukuoka, Japan, 802-8533
    • National Hospital Organization Kokura Medical Center
  • Gunma, Japan, 371-8511
    • Gunma University Hospital
  • Gunma, Japan, 371-0014
    • Maebashi Red Cross Hospital
  • Gunma, Japan, 375-0017
    • Shinozuka Hospital
  • Hiroshima, Japan, 739-0696
    • National Hospital Organization Hiroshima-nishi Medical Ctr.
  • Hyogo, Japan, 650-0017
    • Kobe University Hospital
  • Hyogo, Japan, 651-2273
    • Nishi-Kobe Medical Center
  • Hyogo, Japan, 653-0013
    • Kobe City Hospital Org Kobe City Medical Cente West Hp
  • Iwate, Japan, 020-8505
    • Iwate Medical University Hospital
  • Kagawa, Japan, 761-0793
    • Kagawa University Hospital
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center
  • Kanagawa, Japan, 243-8551
    • Shonan Atsugi Hospital
  • Kanagawa, Japan, 211-8533
    • Nippon Medical School Musashikosugi Hospital
  • Kyoto, Japan, 607-8062
    • Rakuwakai Otowa Hospital
  • Kyoto, Japan, 625-8502
    • National Hospital Organization Maizuru Medical Center
  • Kyoto, Japan, 610-0113
    • National Hospital Organization Minami-Kyoto Hospital
  • Nagano, Japan, 399-0021
    • National Hospital Organization Matsumoto Medical Center
  • Niigata, Japan, 945-8585
    • National Hospital Organization Niigata National Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Okayama, Japan, 701-0304
    • National Hospital Organization Minami-Okayama Medical Center
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Osaka, Japan, 570-8507
    • Kansai Medical University Takii Hospital
  • Shizuoka, Japan, 420-8688
    • National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 136-0075
    • Juntendo Tokyo Koto Geriatric Medical Center
  • Tokyo, Japan, 204-8585
    • National Hospital Organization Tokyo National Hospital
  • Tokyo, Japan, 193-0944
    • Tokyo Medical University Hachioji Medical Center
  • Aichi,
    • Nagoya, Aichi,, Japan, 467-8602
      • Nagoya City University Hospital
  • Tokyo
    • Ota-ku, Tokyo, Japan, 145-0065
      • Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • KonKuk University Hospital, Department of NeuroPsychiatry
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital, Department of Psychiatry
• Mexico
  • Aguascalientes, Mexico, 20127
    • Instituto Biomedico de Investigacion A.C
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64000
      • OCA Hospital
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch ziekenhuis
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Haarlem, Netherlands, 2035 RC
    • Kennemer Gasthuis
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • s. Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch ziekenhuis
• New Zealand
  • Christchurch, New Zealand, 8014
    • Signet Research
  • NZ
    • Auckland, NZ, New Zealand, 0622
      • The Memory Clinic
• Poland
  • Bydgoszcz, Poland, 85-796
    • NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
  • Kielce, Poland, 25-317
    • NZOZ "SYNAPSA", ul. Niska 5/1
  • Krakow, Poland, 31-531
    • Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
  • Poznan, Poland, 61-289
    • NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
  • Warszawa, Poland, 01-211
    • Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
  • Warszawa, Poland, 02-097
    • Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
• Portugal
  • Amadora, Portugal, 2700-276
    • Hospital Fernando da Fonseca
  • Coimbra, Portugal, 3000-075
    • Hospitais da universidade de Coimbra
  • Lisboa, Portugal, 1649-028
    • Hospital Santa Maria
• Russian Federation
  • Kazan, Russian Federation, 420101
    • Interregional clinicodiagnostic center
  • Nizhny Novgorod, Russian Federation, 603126
    • Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
  • Saint-Petersburg, Russian Federation, 190103
    • Saint-Petersburg State institution of healthcare, City geriatric medico-social center
  • Saint-Petersburg, Russian Federation, 192019
    • Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
  • Saint-Petersburg, Russian Federation, 192019
    • Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
  • Saint-Petersburg, Russian Federation, 194044
    • Chair of nervous system diseases
• Serbia
  • Belgrade, Serbia, 11000
    • Klinicki Centar Srbije
  • Beograd, Serbia, 11000
    • Klinicki Centar Srbije
  • Kragujevac, Serbia, 34000
    • Clinical Centre Kragujevac
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Klinicki centar Vojvodine
• Slovakia
  • Bratislava, Slovakia, 825 56
    • Univerzitna nemocnica Bratislava
  • Bratislava, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava
  • Bratislava, Slovakia, 820 07
    • Psychiatricka ambulancia
  • Bratislava, Slovakia, 813 69
    • 1. Neurologicka klinika
  • Martin, Slovakia, 036 59
    • Neurologicka klinika
  • Michalovce, Slovakia, 071 01
    • Psychiatricka nemocnica Michalovce, n.o.
  • Rimavska Sobota, Slovakia, 979 12
    • Vseobecna nemocnica Rimavska Sobota
  • Zilina, Slovakia, 012 07
    • Neurologicke oddelenie FNsP Zilina
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1709
      • Boithuso Caregivers
    • Johannesburg, Gauteng, South Africa, 2196
      • The Osteoporosis and Memory Centre
    • Pretoria, Gauteng, South Africa, 0081
      • Denmar Clinic
  • Kwa Zulu Natal
    • Durban, Kwa Zulu Natal, South Africa, 4001
      • St Augustine's Medical Centre 2
  • Western Cape
    • Panorama, Western Cape, South Africa, 7505
      • Panorama Psychiatry and Memory Clinic
• Spain
  • Baracaldo, Spain, 48903
    • Hospital de Cruces
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08034
    • Clínica CIMA
  • Barcelona, Spain, 08029
    • Fundació ACE Institut Catala de Neurociences Aplicades
  • Burgos, Spain, 09006
    • Hospital Divino Valles
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Mutua de Terrasa
  • Caceres
    • Plasencia, Caceres, Spain, 10600
      • Hospital Virgen del Puerto
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07010
      • Hospital Universitario Son Espases
    • Palma de Mallorca, Islas Baleares, Spain, 07014
      • CLONUS
• Sweden
  • Malmo, Sweden, 21 224
    • Skanes Universitetssjukhus, Neuropsykiatriska
  • Uppsala, Sweden, 751 09
    • PET Center
  • Uppsala, Sweden, 751 85
    • The clinic: Minnes- och geriatrikmottagningen
  • Uppsala, Sweden, 75185
    • MRI Dept: ORKI
• Switzerland
  • Thonex-Geneva, Switzerland, CH-1226
    • Hôpitaux universitaires de Genève
  • BS
    • Basel, BS, Switzerland, CH-4031
      • Memory Clinic Neuro-Psychologie Zentrum
  • GE
    • Les Acacias, GE, Switzerland, 1227
      • Hôpitaux universitaires de Genève
  • VD
    • Lausanne, VD, Switzerland, 1005
      • CHUV Lausanne
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Clinical Investigation and Research Unit (CIRU)
  • Glasgow, United Kingdom, G20 0XA
    • Glasgow Memory Clinic
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, W6 8RF
    • Dept. of Neurosciences Charing Cross Hospital
  • Newcastle upon Tyne, United Kingdom, NE4 5PL
    • Newcastle General Hospital
  • Northampton, United Kingdom, NN1 5BD
    • Northampton General Hospital NHS Trust
  • Penarth, United Kingdom, CF64 2XX
    • LLandough Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital
  • Sheffield, United Kingdom, S35 8QS
    • Grenoside Grange Hospital
  • Swindon, United Kingdom, SN3 6BW
    • Kingshill Research Centre
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY2 0JH
      • MAC UK Neuroscience Ltd
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD3 0DQ
      • MAC UK Neuroscience, Ltd.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85032
      • Jeffrey S. Gitt, DO, PC
    • Phoenix, Arizona, United States, 85032
      • The Compounding Center (IP Mixing Only)
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc.
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Incorporated
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Fresno, California, United States, 93720
      • Margolin Brain Institute
    • Laguna Hills, California, United States, 92653
      • Infusion Care Pharmacey
    • Laguna Hills, California, United States, 92653
      • Senior Clinical Trials, Incorporated
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92354
      • Faculty Physicians and Surgeons of Loma Linda University School of Medicine
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc.
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Diego, California, United States, 92123
      • Sharp Mesa Vista Hospital
    • San Diego, California, United States, 92103
      • Coordinated Clinical Research
    • San Diego, California, United States, 92123
      • Sharp and Children's MRI Center, LLC
    • San Diego, California, United States, 92103
      • Labcorp
    • San Diego, California, United States, 92123
      • Sharp Infusion Therapy Center
    • San Francisco, California, United States, 94109
      • San Francisco Clinical Research Center
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Alpine Clinical Research Center, Inc.
    • Boulder, Colorado, United States, 80304
      • Associated Neurologists, PC
    • Denver, Colorado, United States, 80218
      • The Mile High Research Center
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, PC
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, P.C.
    • Greenwich, Connecticut, United States, 06830
      • Bendheim Cancer Center
    • Greenwich, Connecticut, United States, 06830
      • Center for Healthy Aging
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
    • New Haven, Connecticut, United States, 06511
      • Yale-New Haven Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale PET Center
    • New Haven, Connecticut, United States, 06519
      • Norman S. Werdiger, MD
    • New Haven, Connecticut, United States, 06520
      • Institutional Review Board / Ethics Committee
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Atlantis, Florida, United States, 33462
      • Medical Specialists of the Palm Beaches
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Incorporated
    • Deerfield Beach, Florida, United States, 33064
      • North Broward Medical Center
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Lauderdale, Florida, United States, 33308
      • Neurologic Consultants, P.A.
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34481
      • Advanced Imaging
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Neurological Center
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies Inc
    • Sarasota, Florida, United States, 34243
      • Roskamp Institute
    • Sun City, Florida, United States, 33573
      • South Bay Internal Medicine
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research, Incorporated
    • Columbus, Georgia, United States, 31901
      • Columbus Diagnostic Center (MRI)
    • Columbus, Georgia, United States, 31909
      • Medical Research and Health Education Foundation, Incorporated
    • Decatur, Georgia, United States, 30033
      • Neurostudies.net
    • Decatur, Georgia, United States, 30033
      • Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
    • Lawerenceville, Georgia, United States, 30045
      • Neurostudies.net
    • Lawrenceville, Georgia, United States, 30046
      • Neurostudies.net
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Neurosciences Institute
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61602
      • Methodist Center for Senior Health
    • Peoria, Illinois, United States, 61602
      • Methodist Medical Center Research Department
    • Peoria, Illinois, United States, 61606
      • Methodist Diagnostic Center
    • Springfield, Illinois, United States, 62781
      • Memorial Medical Center
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart Clinic, LLC
    • Mishawaka, Indiana, United States, 46545
      • Psychology Associates
  • Kansas
    • Wichita, Kansas, United States, 67207
      • KU - Wichita
    • Wichitia, Kansas, United States, 67205
      • Drug Shipment/ Storage
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Incorporated
    • Paducah, Kentucky, United States, 42003
      • Radio Pharmacy
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates Inc
    • Shreveport, Louisiana, United States, 71104
      • James Gary Booker, MD, APMC
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Foers Medical Arts Pharmacy
    • Rockville, Maryland, United States, 20850
      • CBH Health, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Bringham and Women's Hospital
    • Boston, Massachusetts, United States, 021147
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • General Clinical Research Center
    • Boston, Massachusetts, United States, 02118
      • IDS Pharmacy
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research, Inc.
    • Newton, Massachusetts, United States, 02459
      • Neurocare, Incorporated
    • Springfield, Massachusetts, United States, 01104
      • Springfield Neurology Associates, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Ann Arbor, Michigan, United States, 48110
      • University of Michigan Health System
    • Ann Arbor, Michigan, United States, 48109-5872
      • University of Michigan Health System
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
    • Lansing, Michigan, United States, 48910
      • Michigan State University
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
    • Flowood, Mississippi, United States, 39232
      • Marty's Pharmacy
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • Montana
    • Great Falls, Montana, United States, 59405
      • Advanced Neurology Specialists
    • Great Falls, Montana, United States, 59405
      • Spectrum Home Solutions
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Inc.
    • Manchester, New Jersey, United States, 08759
      • Alzheimer's Research Corporation
    • Toms River, New Jersey, United States, 08755
      • Memory Enhancement Center of New Jersey, Inc.
  • New York
    • Brewster, New York, United States, 10509
      • Northeast Radiology
    • Liverpool, New York, United States, 13088
      • Neurological Care of Central New York
    • Rochester, New York, United States, 14620
      • AD-CARE, University of Rochester Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester/Strong Memorial Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Clinical Study Center of Asheville, LLC
    • Charlotte, North Carolina, United States, 28211
      • Alzheimer's Memory Center
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America, Incorporated
    • Hickory, North Carolina, United States, 28602
      • The Compounding Pharmacy
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, PA
    • Raleigh, North Carolina, United States, 27607
      • Carolina Neuropsychological Services, Inc.
    • Raleigh, North Carolina, United States, 27607
      • Healthsouth Blue Ridge Surgery Center
    • Raleigh, North Carolina, United States, 27607
      • Wake Radiology Associates
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Imaging at Martha Morehouse
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Hospitals Clinic
    • Toledo, Ohio, United States, 43623
      • Neurology & Neuroscience Center Of Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Professional Corporation of Psychiatry
    • Oklahoma City, Oklahoma, United States, 73112
      • Red River Medical Recearch Center, LLC
    • Oklahoma City, Oklahoma, United States, 73134
      • Flourish Integrative Pharmacy
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Brain Institute
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates
    • Jenkintown, Pennsylvania, United States, 19046
      • Clinical Trial Center, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Memory Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennslyvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania (PET)
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational New Drug Services, IDS Pharmacy
    • Philadelphia, Pennsylvania, United States, 19104
      • UPENN Clinical and Translational Research Center (CTRC)
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurological Associates
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island mood and memory research institute
    • Pawtucket, Rhode Island, United States, 02861
      • Simpson's Pharmacy
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Hospitals and Clinics
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Investigational Drug Service
    • Greer, South Carolina, United States, 29651
      • Radiant Research, Incorporated
    • North Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, PC
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Austin, Texas, United States, 78756
      • Austin Infusion Centers
    • Dallas, Texas, United States, 75214
      • Texas Neurology, P.A.
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • San Antonio, Texas, United States, 78231
      • Integra Clinical Research, Llc
    • San Antonio, Texas, United States, 78231
      • Vista Infusions
    • San Antonio, Texas, United States, 78258
      • Inventive Infusion Solutions
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Vermont
    • Bennington, Vermont, United States, 05201
      • The Memory Clinic
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Healthcare
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Neurology
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia General Clinical Research Center
    • Charlottesville, Virginia, United States, 22908
      • University of Viriginia Investigational Pharmacy
  • Washington
    • Bothell, Washington, United States, 98021
      • Pacific Medical Centers
    • Seattle, Washington, United States, 98144
      • Pacific Medical Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
• Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
• Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

• Significant neurological disease other than AD
• Major psychiatric disorder
• Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
• Women of childbearing potential

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Experimental: Bapineuzumab 0.5 mg/kg	Drug: bapineuzumab; Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Other Names: AAB-001; Drug: bapineuzumab; Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Other Names: AAB-001
Experimental: Bapineuzumab 1.0 mg/kg	Drug: bapineuzumab; Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Other Names: AAB-001; Drug: bapineuzumab; Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Other Names: AAB-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78	The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.	78 weeks
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78	The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.	78 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in Brain Amyloid Burden at Week 71.	Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.	71 Weeks
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.	Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.	71 Weeks
The Change From Baseline in Brain Volume at Week 71	Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.	71 Weeks
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78	The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.	39 Weeks
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78	The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.	39 weeks
Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)	The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.	78 Weeks
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)	The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.	78 weeks
Time to Median Placebo Deterioration on DAD Total Score	The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.	78 Weeks
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)	The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.	78 Weeks
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)	Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.	78 Weeks
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)	Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.	78 Weeks
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)	Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.	78 Weeks
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)	Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.	78 weeks
Change From Baseline in Dependence Scale Total Score at Week 78	The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.	78 Weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78	The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.	78 Weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.
• Lacey L, Bobula J, Rudell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (Estimate): April 28, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: immunotherapy; antibody
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3133K1-3000; B2521001 (Other Identifier: Alias Study Number); 2007-005994-79 (EudraCT Number)