AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT00676143

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

A Phase 3 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 288 sites in 24 countries.

Terminated

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

Official record
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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 88 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
1,100 participants
Where
288 sitesin 24 countries
Study dates
Jan 2008to Nov 2012
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 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable AD, with MMSE score of 16-26, and brain 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, or a major psychiatric disorder
  • Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
  • Woman of childbearing potential

Trial locations and contacts

288 sites in 24 countries.

288 sites in 24 countries

United States111 sites

  • Abington Memorial Hosptial

    Abington, Pennsylvania, 19001

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Abington Neurological Assoc

    Abington, Pennsylvania, 19001

  • University of Michigan Hospital and Health System

    Ann Arbor, Michigan, 48105-2945

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5872

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • University of Michigan Health System

    Ann Arbor, Michigan, 48110

  • JEM Research Institute, LLC

    Atlantis, Florida, 33462

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Medical Specialist of the Palm Beaches

    Atlantis, Florida, 33462

  • The Memory Clinic

    Bennington, Vermont, 05201

  • The Pharmacy

    Bennington, Vermont, 05201

  • Center for Psychiatric Medicine

    Birmingham, Alabama, 35294

  • Participant and Clinical Interactions Resources

    Birmingham, Alabama, 35294

  • UAB Clinical Research Pharmacy-Russell Clinic

    Birmingham, Alabama, 35294

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Massachusetts General Hosptial

    Boston, Massachusetts, 02114

  • Brigham & Womens Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Univeristy ADCRP

    Boston, Massachusetts, 02118

  • General Clincial Research Center (Infusion Location)

    Boston, Massachusetts, 02118

  • IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong

    Boston, Massachusetts, 02118

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado, 80304

  • Associated Neurologists, PC

    Boulder, Colorado, 80304

  • AC Institute, Incorporated

    Carson, California, 90746

  • Medical University of South Carolina Hospitals and Clinics

    Charleston, South Carolina, 29425

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MUSC

    Charleston, South Carolina, 29425

  • Ohio State University Imaging@Martha Moorehouse

    Columbs, Ohio, 43210

  • The Ohio State University

    Columbs, Ohio, 43210

  • The Ohio State University

    Columbus, Ohio, 43210

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

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

    Decatur, Georgia, 30033

  • Neurostudies.net

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • 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

  • Pharmcare USA

    Edison, New Jersey, 08837

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Andorra MRI of Flourtown

    Flourtown, Pennsylvania, 19031

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Bendheim Cancer Center

    Greenwich, Connecticut, 06830

  • Center for Healthy Aging

    Greenwich, Connecticut, 06830

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • The Center for Pharmaceutical Research P.C.

    Kansas City, Missouri, 64114

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • NeuroStudies.net

    Lawrenceville, Georgia, 30045

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Neurological Care of Central New York

    Liverpool, New York, 13088

  • Collaborative Neuroscience Network, Inc

    Long Beach, California, 90806

  • Waisman Center (PET only)

    Madison, Wisconsin, 53705-2280

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53705

  • Wm S. Middleton Memorial Veterans Hospital

    Madison, Wisconsin, 53705

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792

  • Alzheimer's Disease Research Unit

    New Haven, Connecticut, 06510

  • Hospital Research Unit

    New Haven, Connecticut, 06510

  • Investigational Drug Service

    New Haven, Connecticut, 06511

  • Moshe Hasbani, MD

    New Haven, Connecticut, 06511

  • Norman S. Werdiger, MD

    New Haven, Connecticut, 06519

  • MR Research Center

    New Haven, Connecticut, 06520

  • Yale PET Center

    New Haven, Connecticut, 06520

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33418

  • Alzheimer's Research Corp./Merician Institute for Aging

    Paterson, New Jersey, 08759

  • Simpson's Pharmacy

    Pawtucket, Rhode Island, 02861

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Investigational New Drug Services

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania-Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • UPENN Clinical and Transitional Research Center

    Philadelphia, Pennsylvania, 19104

  • Jefferson Hospital for Neuroscience

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Jeffrey S. Gitt, DO, PC

    Phoenix, Arizona, 85032

  • The Compounding Center

    Phoenix, Arizona, 85032

  • HOPE Research Institute

    Phoenix, Arizona, 85050

  • Neuroscience Research of the Berkshires

    Pittsfield, Massachusetts, 01201

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Summit Research Network(Oregon) Inc.

    Portland, Oregon, 97210

  • Providence Brain Institute

    Portland, Oregon, 97225

  • Providence Cognitive Assessment Clinic

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    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

    Raleigh, North Carolina, 27607

  • Wake Radiology Associates

    Raleigh, North Carolina, 27607

  • Shields MRI

    Russells Mills, Massachusetts, 02747

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Integra Clinical Research

    San Antonio, Texas, 78229

  • Integra Clinical Research, LLC

    San Antonio, Texas, 78231

  • Integra Clinical Research

    San Antonio, Texas, 78231

  • Vista Infusions

    San Antonio, Texas, 78231

  • Inventive Infusion Solutions

    San Antonio, Texas, 78258

  • Inventive Infusions Solutions

    San Antonio, Texas, 78258

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Dr. Michael Gabe (Clinic)

    Silverton, Oregon, 97381

  • Southern Illinois University School of Medicine Department

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Springfield Neurology Associates, LLC

    Springfield, Massachusetts, 01104

  • University of South Florida

    Tampa, Florida, 33613

  • 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 Musashi Kosugi Hospital

    Kanagawa, 211-8533

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Shonan Atsugi Hospital

    Kanagawa, 243-8551

  • National Hospital Organization Tokyo National Hospital

    Kiyose, Tokyo, 204-8585

  • 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

  • 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 Metropolitan Health and Med. Treatment Co. Ebara Hosp

    Tokyo, 145-0065

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

Other trials in Japan

France20 sites

  • CHU Pellegrin

    Bordeaux, 33076

  • Hopital neurologique du Pr A. Vighetto

    Bron, 69677

  • Centre d'Imagerie medicale de Basse Normandie

    Caen, 14000

  • CHU de Caen

    Caen, 14033

  • Hôpitaux Civils de Colmar

    Colmar, 68024

  • CHU de Dijon

    Dijon, France, 21033

  • CHRU de Lille

    Lille, 59037

  • Hôpital la Timone

    Marseille, 13385

  • CHU Hôpital Gui de Chaulliac

    Montpellier, 34295

  • CHU Nord - Hôpital Guillaume et René Laënnec

    Nantes - Saint Herblain, 44093

  • Hôpital Cimiez C.M.R.R.

    Nice, 06000

  • Service d'Imagerie Medicale

    Nice, 06002

  • Groupe Hospitalier Broca-La Rochefoucauld

    Paris, 75013

  • Hôpital Pitié-Salpétrière

    Paris, 75651

  • Hospital Jean Bernard CIC

    Poitiers, 86000

  • C.H.U de Reims

    Reims, 51092

  • CHU de Rennes

    Rennes, 35064

  • CHU - Hopital Charles Nicolle

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31059

  • CHU Toulouse - Site Casselardit

    Toulouse, 31300

Other trials in France

Spain18 sites

  • Hospital de Cruces

    Barakaldo, Vizcalla, 48903

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Fundacio ACE Institut Catala de Neurociences Aplicades

    Barcelona, 08014

  • Centro Internacional de Medicina Avanzda (CIMA)

    Barcelona, 08034

  • Hospital Divino Valles

    Burgos, Burgos, 09006

  • Hospital de Donostia

    Donostia / San Sebastian, Basque Country, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital de la Princesa

    Madrid, 28006

  • 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 Terrassa

    Terrassa, Barcelona, 08221

Other trials in Spain

United Kingdom13 sites

  • MAC UK Neuroscience Ltd

    Blackpool, Lancashire, FY2 0JH

  • Pollard Park Health Centre

    Bradford, 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

    Northampton, NN1 5BD

  • Llandough Hospital

    Penarth, CF64 2XX

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Grenoside Grange Hospital

    Sheffield, S35 8QS

  • Victoria Hospital

    Swindon, SN3 6BW

  • MAC UK Neuroscience, Research Assessment Centre

    Trafford Park, Manchester, M32 0UT

Other trials in United Kingdom

Italy11 sites

  • A.O. Umberto I

    Ancona, 60020

  • Sezione di Neurologia - Dipartimento di Neuroscienze

    Ancona, 60020

  • Clinica Neurologica - II Neurologia

    Brescia, 25123

  • Dipartimento di Neuroscienze,

    Catania, 95123

  • Unita' Operativa Complessa di Neurologia

    Catania, 95126

  • CeSI (Centro di Scienze dell'invecchiamento) -

    Chieti, 66013

  • Fondazione IRCCS- Istituto Neurologico Carlo Besta

    Milan, 20133

  • 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

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • CDAMS Ballarat Base Hospital

    Ballarat, Victoria, 3353

  • Gosford Hospital; Pharmacy Dept

    Gosford, New South Wales, 2250

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Hornsby Kuringai Hospital

    Hornsby, New South Wales, 2077

  • Hollywood Hospital; Pharmacy Dept

    Nedlands, Western Australia, 6009

  • McCusker Alzheimer's Research Foundation, Inc.

    Nedlands, Western Australia, 6009

  • Heidelberg Repatriation Hospital

    West Heidelberg, Victoria, 3081

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Netherlands9 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis

    Breda, North Brabant, 4818 CK

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Kennemer Gasthuis

    Haarlem, The Netherlands, 2035 RC

  • Tergooi Ziekenhuizen

    Hilversum, North Holland, 1213 XZ

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Erasmus MC

    Rotterdam, 3015 CE

Other trials in Netherlands

Belgium6 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Az. St. Jan Ruddershove 35

    Bruges, 8000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

Germany6 sites

  • Charite-Universitätsmedizin Berlin

    Berlin, State of Berlin, 14050

  • St. Josef-Klinikum

    Bochum, 44791

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Klinikum der Albert-Ludwigs-Universitaet Freiburg

    Freiburg im Breisgau, 79106

  • Ortenau Klinikum Offenburg

    Offenburg, 77654

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Africa6 sites

  • Flexivest Fourteen Research Center

    Bellville, Western Cape, 7530

  • 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, 7500

  • Denmar Clinic

    Pretoria, Gauteng, 0081

Other trials in South Africa

Argentina5 sites

  • Instituto Medico Congreso

    Buenos Aires, Buenos Aires, 1090

  • Instituto Medico Congreso

    Buenos Aires, 1090

  • Cemic University Hospital

    Buenos Aires, 1431

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD

  • Instituto Kremer

    Córdoba, 5004

Other trials in Argentina

Austria5 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, A-9020

  • Allg. Krankenhaus der Stadt Wien

    Vienna, 1090

  • SZ Sued - Kaiser-Franz-Josef-Spital

    Vienna, 1220

  • Donauspital

    Vienna, A-1220

Other trials in Austria

Poland5 sites

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

    Bydgoszcz, 85-796

  • Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i

    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

Serbia5 sites

  • Klinicki centar Srbije

    Belgrade, 11000

  • Diagnostic Imaging Center

    Kamenitz, 21204

  • Institute for Cardiovascular Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Centre Kragujevac, Clinic of Psichiatry

    Kragujevac, 34000

  • Klinicki Centar Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Slovakia4 sites

  • Psychiatricka ambulancia

    Bratislava, 820 07

  • Univerzitna nemocnica Bratislava

    Bratislava, 825 56

  • Psychiatricka nemocnica Michalovce, n.o.

    Michalovce, 071 01

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

Other trials in Slovakia

Sweden4 sites

  • Malmo University Hospital

    Malmö, 21 224

  • Uppsala Imanet AB

    Uppsala, 751 09

  • Akademiska Sjukhuset

    Uppsala, 75185

  • ORKI, enheten for radiologi

    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, 2720-276

  • Hospitais Da Universidade De Coimbra

    Coimbra, Coimbra District, 3000-075

  • Hospital Santa Maria

    Lisbon, Lisbon District, 1649-028

Other trials in Portugal

Chile2 sites

  • Psicomedica Research Group

    Santiago, Chile, 7530193

  • Especialidades Medicas LyS

    Santiago

Other trials in Chile

Finland2 sites

  • Ita-Suomen Yliopisto

    Kuopio, FIN-70210

  • University of Turku / CRST

    Turku, 20520

Other trials in Finland

Mexico2 sites

  • Instituto Biomedico de Investigacion A.C

    Aguascalientes, 20127

  • OCA Hospital

    Monterrey, Nuevo León, 64000

Other trials in Mexico

New Zealand2 sites

  • The Memory Clinic

    Auckland, NZ, 0622

  • Signet Research

    Christchurch, 8014

Other trials in New Zealand

Croatia1 site

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: A Phase Iii, 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 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.

  • placeboDrug

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

Study groups in NCT00676143
Study groupRoleWhat they receive
Bapineuzumab 0.5 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. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale 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: Baseline and 78 weeks

  2. Change From Baseline in Disability Assessment for Dementia (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 psychometric 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: Baseline and 78 weeks

Secondary outcomes (15)

  1. 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 semi-quantitative 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: Baseline and 71 weeks

  2. Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71

    Biomarkers CSF phospho-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: Baseline and 71 Weeks

  3. Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71

    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: Baseline and 71 Weeks

  4. Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78

    Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.

    Measured: Week 39 to Week 78

  5. Divergence of Effect on the DAD Total Scores From Week 39 to Week 78

    Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.

    Measured: Week 39 to Week 78

  6. Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)

    The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline 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 median time to first median placebo deterioration was presented.

    Measured: Baseline and 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 was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.

    Measured: Baseline and 78 Weeks

  8. Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)

    The time to first median placebo deterioration 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: Baseline and 78 Weeks

  9. Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)

    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: Baseline and 78 Weeks

  10. 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: Baseline and 78 Weeks

  11. Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)

    Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining "deterioration" for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.

    Measured: Baseline and 78 Weeks

  12. Percentage of Responders for 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 was <7.

    Measured: Baseline and 78 Weeks

  13. Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)

    Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining "deterioration" for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.

    Measured: Baseline and 78 Weeks

  14. Percentage of Responders for 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: Baseline and 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: Baseline and 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 posted12 May 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2012
  4. Study completionNov 2012

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
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676143
Sponsor's protocol ID
3133K1-3001
Other IDs
B2521002, 2007-005995-14
Status last verified
May 2016
First submitted
2 May 2008
Last updated
10 Jun 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 288 sites in 24 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 3 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, Japan, France, Spain, United Kingdom and 19 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 10 Jun 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?

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78 (time frame: Baseline and 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 NCT00676143, 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 10 Jun 2016.

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