AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT00667810

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

A Phase 3 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 346 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Alzheimer Disease
What is being tested?
bapineuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
901 participants
Where
346 sitesin 26 countries
Study dates
Jun 2008to Aug 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

346 sites in 26 countries.

346 sites in 26 countries

United States164 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5872

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • University of Michigan Health System

    Ann Arbor, Michigan, 48110

  • Clinical Study Center of Asheville, LLC

    Asheville, North Carolina, 28803

  • NeuroTrials Research, Incorporated

    Atlanta, Georgia, 30342

  • JEM Research Institute LLC

    Atlantis, Florida, 33462

  • Medical Specialists of the Palm Beaches

    Atlantis, Florida, 33462

  • Austin Infusion Centers

    Austin, Texas, 78756

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Southwestern Vermont Healthcare

    Bennington, Vermont, 05201

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Foers Medical Arts Pharmacy

    Bethesda, Maryland, 20814

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 021147

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bringham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University

    Boston, Massachusetts, 02118

  • General Clinical Research Center

    Boston, Massachusetts, 02118

  • IDS Pharmacy

    Boston, Massachusetts, 02118

  • Pacific Medical Centers

    Bothell, Washington, 98021

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado, 80304

  • Associated Neurologists, PC

    Boulder, Colorado, 80304

  • Bradenton Research Center, Incorporated

    Bradenton, Florida, 34205

  • Northeast Radiology

    Brewster, New York, 10509

  • Medical University of South Carolina Hospitals and Clinics

    Charleston, South Carolina, 29425

  • Medical University of South Carolina Investigational Drug Service

    Charleston, South Carolina, 29425

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28211

  • University of Virginia Neurology

    Charlottesville, Virginia, 22903

  • University of Virginia General Clinical Research Center

    Charlottesville, Virginia, 22908

  • University of Viriginia Investigational Pharmacy

    Charlottesville, Virginia, 22908

  • Columbus Diagnostic Center (MRI)

    Columbus, Georgia, 31901

  • Medical Research and Health Education Foundation, Incorporated

    Columbus, Georgia, 31909

  • Ohio State University Imaging at Martha Morehouse

    Columbus, Ohio, 43210

  • The Ohio State University Hospitals Clinic

    Columbus, Ohio, 43210

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • The Ohio State University

    Columbus, Ohio, 43210

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Incorporated

    Costa Mesa, California, 92626

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • NeuroStudies.net

    Decatur, Georgia, 30033

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • The Mile High Research Center

    Denver, Colorado, 80218

  • Michigan State University

    East Lansing, Michigan, 48824

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Alexian Brothers Neurosciences Institute

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514

  • Pharmacology Research Institute

    Encino, California, 91316

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Marty's Pharmacy

    Flowood, Mississippi, 39232

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neurologic Consultants, P.A.

    Fort Lauderdale, Florida, 33308

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Margolin Brain Institute

    Fresno, California, 93720

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405

  • Spectrum Home Solutions

    Great Falls, Montana, 59405

  • Bendheim Cancer Center

    Greenwich, Connecticut, 06830

  • Center for Healthy Aging

    Greenwich, Connecticut, 06830

  • Radiant Research, Incorporated

    Greer, South Carolina, 29651

  • MD Clinical

    Hallandale, Florida, 33009

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • ActivMed Practices and Research, Inc.

    Haverhill, Massachusetts, 01830

  • Clinical Trials of America, Incorporated

    Hickory, North Carolina, 28601

  • The Compounding Pharmacy

    Hickory, North Carolina, 28602

  • Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Infusion Care Pharmacey

    Laguna Hills, California, 92653

  • Senior Clinical Trials, Incorporated

    Laguna Hills, California, 92653

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Michigan State University

    Lansing, Michigan, 48910

  • Neurostudies.net

    Lawerenceville, Georgia, 30045

  • Neurostudies.net

    Lawrenceville, Georgia, 30046

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Neurological Care of Central New York

    Liverpool, New York, 13088

  • Faculty Physicians and Surgeons of Loma Linda University School of Medicine

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Collaborative Neuroscience Network, Inc.

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Psychology Associates

    Mishawaka, Indiana, 46545

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06511

  • Norman S. Werdiger, MD

    New Haven, Connecticut, 06519

  • Institutional Review Board / Ethics Committee

    New Haven, Connecticut, 06520

  • Yale PET Center

    New Haven, Connecticut, 06520

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Louisiana Research Associates Inc

    New Orleans, Louisiana, 70114

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Neurocare, Incorporated

    Newton, Massachusetts, 02459

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Advanced Imaging

    Ocala, Florida, 34481

  • Professional Corporation of Psychiatry

    Oklahoma City, Oklahoma, 73112

  • Red River Medical Recearch Center, LLC

    Oklahoma City, Oklahoma, 73112

  • Flourish Integrative Pharmacy

    Oklahoma City, Oklahoma, 73134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Four Rivers Clinical Research, Incorporated

    Paducah, Kentucky, 42003

  • Radio Pharmacy

    Paducah, Kentucky, 42003

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Simpson's Pharmacy

    Pawtucket, Rhode Island, 02861

  • Methodist Center for Senior Health

    Peoria, Illinois, 61602

  • Methodist Medical Center Research Department

    Peoria, Illinois, 61602

  • Methodist Diagnostic Center

    Peoria, Illinois, 61606

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Hospital of the University of Pennslyvania

    Philadelphia, Pennsylvania, 19104

  • Hospital of the University of Pennsylvania (PET)

    Philadelphia, Pennsylvania, 19104

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Investigational New Drug Services, IDS Pharmacy

    Philadelphia, Pennsylvania, 19104

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • UPENN Clinical and Translational Research Center (CTRC)

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Jeffrey S. Gitt, DO, PC

    Phoenix, Arizona, 85032

  • The Compounding Center (IP Mixing Only)

    Phoenix, Arizona, 85032

  • Hope Research Institute

    Phoenix, Arizona, 85050

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Providence Brain Institute

    Portland, Oregon, 97225

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Carolina Neuropsychological Services, Inc.

    Raleigh, North Carolina, 27607

  • Healthsouth Blue Ridge Surgery Center

    Raleigh, North Carolina, 27607

  • Raleigh Neurology Associates, PA

    Raleigh, North Carolina, 27607

  • Wake Radiology Associates

    Raleigh, North Carolina, 27607

  • AD-CARE, University of Rochester Medical Center

    Rochester, New York, 14620

  • University of Rochester/Strong Memorial Hospital

    Rochester, New York, 14642

  • CBH Health, LLC

    Rockville, Maryland, 20850

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Integra Clinical Research, LLC

    San Antonio, Texas, 78231

  • Vista Infusions

    San Antonio, Texas, 78231

  • Inventive Infusion Solutions

    San Antonio, Texas, 78258

  • Coordinated Clinical Research

    San Diego, California, 92103

  • LabCorp

    San Diego, California, 92103

  • Sharp and Children's MRI Center, LLC

    San Diego, California, 92123

  • Sharp Infusion Therapy Center

    San Diego, California, 92123

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Pacific Medical Centers

    Seattle, Washington, 98144

  • James Gary Booker, MD, APMC

    Shreveport, Louisiana, 71104

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Springfield Neurology Associates, LLC

    Springfield, Massachusetts, 01104

  • South Bay Internal Medicine

    Sun City, Florida, 33573

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Neurology & Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Memory Enhancement Center of New Jersey, Inc.

    Toms River, New Jersey, 08755

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • KU - Wichita

    Wichita, Kansas, 67207

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • Drug Shipment/ Storage

    Wichitia, Kansas, 67205

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Japan35 sites

  • Yachiyo Hospital

    Aichi, 446-8510

  • Kashiwado Hospital

    Chiba, 260-8656

  • National Hospital Organization Chiba-East Hospital

    Chiba, 260-8712

  • Nippon Medical School Chiba Hokusoh Hospital

    Chiba, 270-1694

  • National Hospital Organization Kokura Medical Center

    Fukuoka, 802-8533

  • Maebashi Red Cross Hospital

    Gunma, 371-0014

  • Gunma University Hospital

    Gunma, 371-8511

  • Shinozuka Hospital

    Gunma, 375-0017

  • National Hospital Organization Hiroshima-nishi Medical Ctr.

    Hiroshima, 739-0696

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Nishi-Kobe Medical Center

    Hyōgo, 651-2273

  • Kobe City Hospital Org Kobe City Medical Cente West Hp

    Hyōgo, 653-0013

  • Kagawa University Hospital

    Kagawa, 761-0793

  • Nippon Medical School Musashikosugi Hospital

    Kanagawa, 211-8533

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Shonan Atsugi Hospital

    Kanagawa, 243-8551

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062

  • National Hospital Organization Minami-Kyoto Hospital

    Kyoto, 610-0113

  • National Hospital Organization Maizuru Medical Center

    Kyoto, 625-8502

  • National Hospital Organization Matsumoto Medical Center

    Nagano, 399-0021

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Niigata National Hospital

    Niigata, 945-8585

  • Iwate Medical University Hospital

    Numakunai, 020-8505

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Minami-Okayama Medical Center

    Okayama, 701-0304

  • Osaka City University Hospital

    Osaka, 545-8586

  • Osaka University Hospital

    Osaka, 565-0871

  • Kansai Medical University Takii Hospital

    Osaka, 570-8507

  • Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp

    Ōta-ku, Tokyo, 145-0065

  • National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

    Shizuoka, 420-8688

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo, 136-0075

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0944

  • National Hospital Organization Tokyo National Hospital

    Tokyo, 204-8585

Other trials in Japan

France19 sites

  • CHU Hopital Nord

    Amiens, 80054

  • Hôpital Neurologique

    Bron, 69677

  • CHU de Caen

    Caen, 14033

  • Hôpitaux Civils de Colmar

    Colmar, 68024

  • CHU de Dijon

    Dijon, France, 21000

  • Hôpital Roger Salengro

    Lille, 59037

  • Hopital Sainte Marguerite

    Marseille, 13009

  • Hôpital la Timone

    Marseille, 13885

  • CHU Hôpital Gui de Chaulliac

    Montpellier, 34295

  • CHU Nord - Hôpital Guillaume et René Laënnec

    Nantes - Saint Herblain, 44093

  • Hôpital Cimiez

    Nice, 06000

  • Groupe Hospitalier Broca-La Rochefoucauld

    Paris, 75013

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

  • CHU La Milétrie

    Poitiers, 86021

  • C.H.U de Reims

    Reims, 51000

  • CHRU Hôtel Dieu

    Rennes, Cedex, 35064

  • CHU - Hopital Charles Nicolle

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31059

  • CHU Purpan - Hôpital Casselardit

    Toulouse, 31300

Other trials in France

Spain17 sites

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Clínica CIMA

    Barcelona, Barcelona, 08034

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Fundació ACE Institut Catala de Neurociences Aplicades

    Barcelona, 08029

  • Hospital Divino Valles

    Burgos, Burgos, 09006

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • CLONUS

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Virgen del Puerto

    Plasencia, Caceres, 10600

  • Hospital Mutua de Terrasa

    Terrassa, Barcelona, 08221

Other trials in Spain

Italy13 sites

  • Universita Politecnica delle Marche

    Ancona, 60020

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Unita' Operativa Complessa di Neurologia

    Catania, 95126

  • CeSI (Centro di Scienze dell'invecchiamento) -

    Chieti, 66013

  • Universita degli Studi di Firenze

    Florence, 50131

  • Ospedale S. Raffaele

    Milan, 20127

  • Ospedale S. Raffaele

    Milan, 20132

  • Fondazione IRCCS- Istituto Neurologico Carlo Besta

    Milan, 20133

  • Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca

    Monza, 20052

  • Ospedale S. Gerardo

    Monza, 20052

  • Clinica Neurologica

    Roma, 00128

  • Unita' Operativa C - Riabilitazione Neurologica

    Roma, 00179

  • Universita degli Studi di Siena

    Siena, 53100

Other trials in Italy

United Kingdom12 sites

  • MAC UK Neuroscience Ltd

    Blackpool, Lancashire, FY2 0JH

  • MAC UK Neuroscience, Ltd.

    Bradford, West Yorkshire, BD3 0DQ

  • Clinical Investigation and Research Unit (CIRU)

    Brighton, BN2 5BE

  • Glasgow Memory Clinic

    Glasgow, Glasgow, G20 0XA

  • Kings College Hospital

    London, London, SE5 9RS

  • Dept. of Neurosciences Charing Cross Hospital

    London, W6 8RF

  • Newcastle General Hospital

    Newcastle upon Tyne, NE4 5PL

  • Northampton General Hospital NHS Trust

    Northampton, NN1 5BD

  • Llandough Hospital

    Penarth, CF64 2XX

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Grenoside Grange Hospital

    Sheffield, S35 8QS

  • Kingshill Research Centre

    Swindon, SN3 6BW

Other trials in United Kingdom

Canada9 sites

  • Centre de Recherche ADAPRA Inc.

    L'Ancienne-Lorette, Quebec, G2E 2X1

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Recherche Clinique de Neurologie

    Montreal, Quebec, H1T 2M4

  • Centre for Memory and Aging

    North York, Ontario, M6M 3Z5

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide SA, 5000

  • CDAMS Ballarat Base Hospital

    Ballarat, Victoria, 3353

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Hornsby Kuringai Hospital

    Hornsby, New South Wales, 02077

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • McCusker Alzheimer's Research Foundation Inc.

    Nedlands, Western Australia, 6009

  • Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit

    West Heidelberg, Victoria, 3081

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Slovakia8 sites

  • 1. Neurologicka klinika

    Bratislava, 813 69

  • Psychiatricka ambulancia

    Bratislava, 820 07

  • Univerzitna nemocnica Bratislava

    Bratislava, 825 56

  • Univerzitna nemocnica Bratislava

    Bratislava, 826 06

  • Neurologicka klinika

    Martin, 036 59

  • Psychiatricka nemocnica Michalovce, n.o.

    Michalovce, 071 01

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

  • Neurologicke oddelenie FNsP Zilina

    Žilina, 012 07

Other trials in Slovakia

Belgium6 sites

  • ZNA Middelheim / Neurologie

    Antwerp, 2020

  • Az. St. Jan Ruddershove 35

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • University Hospital Gathuisberg

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

Netherlands6 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Kennemer Gasthuis

    Haarlem, 2035 RC

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

Other trials in Netherlands

Poland6 sites

  • NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.

    Bydgoszcz, 85-796

  • NZOZ "SYNAPSA", ul. Niska 5/1

    Kielce, 25-317

  • Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych

    Krakow, Poland, 31-531

  • NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

    Poznan, Poland, 61-289

  • Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,

    Warsaw, 01-211

  • Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

    Warsaw, 02-097

Other trials in Poland

Russia6 sites

  • Interregional clinicodiagnostic center

    Kazan', 420101

  • Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko

    Nizhny Novgorod, 603126

  • Saint-Petersburg State institution of healthcare, City geriatric medico-social center

    Saint Petersburg, 190103

  • Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

    Saint Petersburg, 192019

  • Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

    Saint Petersburg, 192019

  • Chair of nervous system diseases

    Saint Petersburg, 194044

Other trials in Russia

South Africa5 sites

  • St Augustine's Medical Centre 2

    Durban, KwaZulu-Natal, 4001

  • Boithuso Caregivers

    Johannesburg, Gauteng, 1709

  • The Osteoporosis and Memory Centre

    Johannesburg, Gauteng, 2196

  • Panorama Psychiatry and Memory Clinic

    Panorama, Western Cape, 7505

  • Denmar Clinic

    Pretoria, Gauteng, 0081

Other trials in South Africa

Germany4 sites

  • Klinik fur Psychiatrie und Psychotherapie

    Berlin, State of Berlin, 14050

  • St. Josef-Klinikum

    Bochum, 44791

  • Ortenau Klinikum

    Offenburg, 77654

  • Universitaet Regensburg

    Regensburg, 93053

Other trials in Germany

Sweden4 sites

  • Skanes Universitetssjukhus, Neuropsykiatriska

    Malmö, 21 224

  • PET center

    Uppsala, 751 09

  • The clinic: Minnes- och geriatrikmottagningen

    Uppsala, 751 85

  • MRI Dept: ORKI

    Uppsala, 75185

Other trials in Sweden

Switzerland4 sites

  • Memory Clinic Neuro-Psychologie Zentrum

    Basel, Canton of Basel-City, CH-4031

  • CHUV Lausanne

    Lausanne, Canton of Vaud, 1005

  • Hopitaux Universitaires de Geneve

    Les Acacias, Canton of Geneva, 1227

  • Hopitaux Universitaires de Geneve

    Thonex-Geneva, CH-1226

Other trials in Switzerland

Portugal3 sites

  • Hospital Fernando da Fonseca

    Amadora, Amadora, 2700-276

  • Hospitais Da Universidade De Coimbra

    Coimbra, Coimbra District, 3000-075

  • Hospital Santa Maria

    Lisbon, Lisbon District, 1649-028

Other trials in Portugal

Serbia3 sites

  • Klinicki centar Srbije

    Belgrade, 11000

  • Clinical Centre Kragujevac

    Kragujevac, 34000

  • Klinicki centar Vojvodine

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Argentina2 sites

  • Cemic University Hospital

    Buenos Aires, 1431

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

Other trials in Argentina

Chile2 sites

  • Psicomedica Research Group

    Santiago, Chile, 7530193

  • Especialidades Medicas L&S

    Santiago

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Croatia2 sites

  • Sestre milosrdnice Zagreb

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Finland2 sites

  • Ita-Suomen Yliopisto

    Kuopio, FIN-70210

  • Turku University Hospital

    Turku, Finland, 20520

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Mexico2 sites

  • Instituto Biomedico de Investigacion A.C

    Aguascalientes, 20127

  • OCA Hospital

    Monterrey, Nuevo León, 64000

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New Zealand2 sites

  • The Memory Clinic

    Auckland, NZ, 0622

  • Signet Research

    Christchurch, 8014

Other trials in New Zealand

South Korea2 sites

  • Seoul National University Bundang Hospital, Department of Psychiatry

    Seongnam-si, Gyeonggi-do, 463-707

  • KonKuk University Hospital, Department of NeuroPsychiatry

    Seoul, 143-729

Other trials in South Korea

About this study

Official title: 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.

Being tested
bapineuzumab, placebo
Keywords
antibody, immunotherapy
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bapineuzumabDrug

    Also called AAB-001

    Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

  • bapineuzumabDrug

    Also called AAB-001

    Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

  • placeboDrug

    Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Study groups in NCT00667810
Study groupRoleWhat they receive
Bapineuzumab 0.5 mg/kgExperimentalNot described
Receives: Drug: bapineuzumab
Bapineuzumab 1.0 mg/kgExperimentalNot described
Receives: Drug: bapineuzumab
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 78 weeks

  2. 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.

    Measured: 78 weeks

Secondary outcomes (15)

  1. 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.

    Measured: 71 Weeks

  2. 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.

    Measured: 71 Weeks

  3. 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.

    Measured: 71 Weeks

  4. 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.

    Measured: 39 Weeks

  5. 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.

    Measured: 39 weeks

  6. 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.

    Measured: 78 Weeks

  7. 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.

    Measured: 78 weeks

  8. 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.

    Measured: 78 Weeks

  9. 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.

    Measured: 78 Weeks

  10. 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.

    Measured: 78 Weeks

  11. 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.

    Measured: 78 Weeks

  12. 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.

    Measured: 78 Weeks

  13. 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.

    Measured: 78 weeks

  14. 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.

    Measured: 78 Weeks

  15. 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.

    Measured: 78 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2012
  4. Study completionAug 2013

Why it stopped: The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
901 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667810
Sponsor's protocol ID
3133K1-3000
Other IDs
B2521001, 2007-005994-79
Status last verified
Dec 2015
First submitted
24 Apr 2008
Last updated
8 Jan 2016
Data monitoring committee
Yes

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.

    PubMed 27176461

  • 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.

    PubMed 26297092

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 346 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 346 sites in United States, Japan, France, Spain, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78 (time frame: 78 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667810, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.

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