Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
NCT ID: NCT00676143
Last Updated: 2016-06-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1100 participants
INTERVENTIONAL
2008-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bapineuzumab 0.5 mg/kg
bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Placebo
placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Interventions
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bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
* Caregiver will participate and be able to attend clinic visits with patient.
Exclusion Criteria
* Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
* Woman of childbearing potential
50 Years
88 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Pennsylvania-Penn Memory Center
Philadelphia, Pennsylvania, United States
Center for Psychiatric Medicine
Birmingham, Alabama, United States
Participant and Clinical Interactions Resources
Birmingham, Alabama, United States
UAB Clinical Research Pharmacy-Russell Clinic
Birmingham, Alabama, United States
University of Alabama-Birmingham
Birmingham, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Jeffrey S. Gitt, DO, PC
Phoenix, Arizona, United States
The Compounding Center
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
AC Institute, Incorporated
Carson, California, United States
Collaborative Neuroscience Network, Inc
Long Beach, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Associated Neurologists, PC
Boulder, Colorado, United States
Mile HIgh Research Center
Denver, Colorado, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
Bendheim Cancer Center
Greenwich, Connecticut, United States
Center for Healthy Aging
Greenwich, Connecticut, United States
Alzheimer's Disease Research Unit
New Haven, Connecticut, United States
Hospital Research Unit
New Haven, Connecticut, United States
Investigational Drug Service
New Haven, Connecticut, United States
Moshe Hasbani, MD
New Haven, Connecticut, United States
Norman S. Werdiger, MD
New Haven, Connecticut, United States
MR Research Center
New Haven, Connecticut, United States
Yale PET Center
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
JEM Research Institute, LLC
Atlantis, Florida, United States
JEM Research Institute
Atlantis, Florida, United States
Medical Specialist of the Palm Beaches
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Roskamp Institute
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
Decatur, Georgia, United States
Neurostudies.net
Decatur, Georgia, United States
NeuroStudies.net
Lawrenceville, Georgia, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Southern Illinois University School of Medicine Department
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hosptial
Boston, Massachusetts, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Univeristy ADCRP
Boston, Massachusetts, United States
General Clincial Research Center (Infusion Location)
Boston, Massachusetts, United States
IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong
Boston, Massachusetts, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States
Shields MRI
Russells Mills, Massachusetts, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
University of Michigan Hospital and Health System
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
The Center for Pharmaceutical Research P.C.
Kansas City, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Pharmcare USA
Edison, New Jersey, United States
Alzheimer's Research Corp./Merician Institute for Aging
Paterson, New Jersey, United States
Neurological Care of Central New York
Liverpool, New York, United States
Carolina Neuropsychological Services, Inc
Raleigh, North Carolina, United States
Healthsouth Blue Ridge Surgery Center
Raleigh, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Wake Radiology Associates
Raleigh, North Carolina, United States
Ohio State University Imaging@Martha Moorehouse
Columbs, Ohio, United States
The Ohio State University
Columbs, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Summit Research Network(Oregon) Inc.
Portland, Oregon, United States
Providence Brain Institute
Portland, Oregon, United States
Providence Cognitive Assessment Clinic
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Dr. Michael Gabe (Clinic)
Silverton, Oregon, United States
Abington Memorial Hosptial
Abington, Pennsylvania, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Abington Neurological Assoc
Abington, Pennsylvania, United States
Andorra MRI of Flourtown
Flourtown, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Investigational New Drug Services
Philadelphia, Pennsylvania, United States
UPENN Clinical and Transitional Research Center
Philadelphia, Pennsylvania, United States
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States
Simpson's Pharmacy
Pawtucket, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MUSC
Charleston, South Carolina, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
Texas Neurology, P.A.
Dallas, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
Integra Clinical Research, LLC
San Antonio, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
Vista Infusions
San Antonio, Texas, United States
Inventive Infusion Solutions
San Antonio, Texas, United States
Inventive Infusions Solutions
San Antonio, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
The Pharmacy
Bennington, Vermont, United States
Waisman Center (PET only)
Madison, Wisconsin, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Wm S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Instituto Medico Congreso
Buenos Aires, Buenos Aires, Argentina
Instituto Medico Congreso
Buenos Aires, , Argentina
Cemic University Hospital
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Instituto Kremer
Córdoba, , Argentina
Gosford Hospital; Pharmacy Dept
Gosford, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Hornsby Kuringai Hospital
Hornsby, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
CDAMS Ballarat Base Hospital
Ballarat, Victoria, Australia
Heidelberg Repatriation Hospital
West Heidelberg, Victoria, Australia
Hollywood Hospital; Pharmacy Dept
Nedlands, Western Australia, Australia
McCusker Alzheimer's Research Foundation, Inc.
Nedlands, Western Australia, Australia
Medizinische Universitaet Graz
Graz, , Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
Allg. Krankenhaus der Stadt Wien
Vienna, , Austria
SZ Sued - Kaiser-Franz-Josef-Spital
Vienna, , Austria
Donauspital
Vienna, , Austria
ZNA Middelheim
Antwerp, , Belgium
Az. St. Jan Ruddershove 35
Bruges, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, , Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare, , Belgium
Psicomedica Research Group
Santiago, Chile, Chile
Especialidades Medicas LyS
Santiago, , Chile
University Hospital Center Zagreb
Zagreb, , Croatia
Ita-Suomen Yliopisto
Kuopio, , Finland
University of Turku / CRST
Turku, , Finland
CHU de Dijon
Dijon, France, France
CHU Pellegrin
Bordeaux, , France
Hopital neurologique du Pr A. Vighetto
Bron, , France
Centre d'Imagerie medicale de Basse Normandie
Caen, , France
CHU de Caen
Caen, , France
Hôpitaux Civils de Colmar
Colmar, , France
CHRU de Lille
Lille, , France
Hôpital la Timone
Marseille, , France
CHU Hôpital Gui de Chaulliac
Montpellier, , France
CHU Nord - Hôpital Guillaume et René Laënnec
Nantes - Saint Herblain, , France
Hôpital Cimiez C.M.R.R.
Nice, , France
Service d'Imagerie Medicale
Nice, , France
Groupe Hospitalier Broca-La Rochefoucauld
Paris, , France
Hôpital Pitié-Salpétrière
Paris, , France
Hospital Jean Bernard CIC
Poitiers, , France
C.H.U de Reims
Reims, , France
CHU de Rennes
Rennes, , France
CHU - Hopital Charles Nicolle
Rouen, , France
Hôpital Purpan
Toulouse, , France
CHU Toulouse - Site Casselardit
Toulouse, , France
Charite-Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
St. Josef-Klinikum
Bochum, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Klinikum der Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, , Germany
Ortenau Klinikum Offenburg
Offenburg, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
A.O. Umberto I
Ancona, , Italy
Sezione di Neurologia - Dipartimento di Neuroscienze
Ancona, , Italy
Clinica Neurologica - II Neurologia
Brescia, , Italy
Dipartimento di Neuroscienze,
Catania, , Italy
Unita' Operativa Complessa di Neurologia
Catania, , Italy
CeSI (Centro di Scienze dell'invecchiamento) -
Chieti, , Italy
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milan, , Italy
Ospedale S. Gerardo
Monza, , Italy
Clinica Neurologica
Roma, , Italy
Unita' Operativa C - Riabilitazione Neurologica
Roma, , Italy
Universita degli Studi di Siena
Siena, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, Japan
Yachiyo Hospital
Aichi, , Japan
Kashiwado Hospital
Chiba, , Japan
National Hospital Organization Chiba-East Hospital
Chiba, , Japan
Nippon Medical School Chiba Hokusoh Hospital
Chiba, , Japan
National Hospital Organization Kokura Medical Center
Fukuoka, , Japan
Maebashi Red Cross Hospital
Gunma, , Japan
Gunma University Hospital
Gunma, , Japan
Shinozuka Hospital
Gunma, , Japan
National Hospital Organization Hiroshima-nishi Medical Ctr.
Hiroshima, , Japan
Kobe University Hospital
Hyōgo, , Japan
Nishi-Kobe Medical Center
Hyōgo, , Japan
Kobe City Hospital Org Kobe City Medical Cente West Hp
Hyōgo, , Japan
Kagawa University Hospital
Kagawa, , Japan
Nippon Medical School Musashi Kosugi Hospital
Kanagawa, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Shonan Atsugi Hospital
Kanagawa, , Japan
Rakuwakai Otowa Hospital
Kyoto, , Japan
National Hospital Organization Minami-Kyoto Hospital
Kyoto, , Japan
National Hospital Organization Maizuru Medical Center
Kyoto, , Japan
National Hospital Organization Matsumoto Medical Center
Nagano, , Japan
National Hospital Organization Niigata National Hospital
Niigata, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
Okayama University Hospital
Okayama, , Japan
National Hospital Organization Minami-Okayama Medical Center
Okayama, , Japan
Osaka City University Hospital
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Kansai Medical University Takii Hospital
Osaka, , Japan
National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
Shizuoka, , Japan
Juntendo University Hospital
Tokyo, , Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, , Japan
Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, , Japan
OCA Hospital
Monterrey, Nuevo León, Mexico
Instituto Biomedico de Investigacion A.C
Aguascalientes, , Mexico
Amphia Ziekenhuis
Breda, North Brabant, Netherlands
Tergooi Ziekenhuizen
Hilversum, North Holland, Netherlands
Kennemer Gasthuis
Haarlem, The Netherlands, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
The Memory Clinic
Auckland, NZ, New Zealand
Signet Research
Christchurch, , New Zealand
Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i
Krakow, Poland, Poland
NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
Poznan, Poland, Poland
NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
Bydgoszcz, , Poland
Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
Warsaw, , Poland
Hospital Fernando da Fonseca
Amadora, Amadora, Portugal
Hospitais Da Universidade De Coimbra
Coimbra, Coimbra District, Portugal
Hospital Santa Maria
Lisbon, Lisbon District, Portugal
Klinicki centar Srbije
Belgrade, , Serbia
Diagnostic Imaging Center
Kamenitz, , Serbia
Institute for Cardiovascular Diseases of Vojvodina
Kamenitz, , Serbia
Clinical Centre Kragujevac, Clinic of Psichiatry
Kragujevac, , Serbia
Klinicki Centar Vojvodina
Novi Sad, , Serbia
Psychiatricka ambulancia
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Psychiatricka nemocnica Michalovce, n.o.
Michalovce, , Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, , Slovakia
Boithuso Caregivers
Johannesburg, Gauteng, South Africa
The Osteoporosis and Memory Centre
Johannesburg, Gauteng, South Africa
Denmar Clinic
Pretoria, Gauteng, South Africa
St Augustine's Medical Centre 2
Durban, KwaZulu-Natal, South Africa
Flexivest Fourteen Research Center
Bellville, Western Cape, South Africa
Panorama Psychiatry and Memory Clinic
Panorama, Western Cape, South Africa
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
CLONUS
Palma de Mallorca, Balearic Islands, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital de Donostia
Donostia / San Sebastian, Basque Country, Spain
Hospital Divino Valles
Burgos, Burgos, Spain
Hospital Virgen del Puerto
Plasencia, Caceres, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital de Cruces
Barakaldo, Vizcalla, Spain
Fundacio ACE Institut Catala de Neurociences Aplicades
Barcelona, , Spain
Centro Internacional de Medicina Avanzda (CIMA)
Barcelona, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Malmo University Hospital
Malmo, , Sweden
Uppsala Imanet AB
Uppsala, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
ORKI, enheten for radiologi
Uppsala, , Sweden
Memory Clinic Neuro-Psychologie Zentrum
Basel, Canton of Basel-City, Switzerland
Hopitaux Universitaires de Geneve
Les Acacias, Canton of Geneva, Switzerland
CHUV Lausanne
Lausanne, Canton of Vaud, Switzerland
Hopitaux Universitaires de Geneve
Thonex-Geneva, , Switzerland
Glasgow Memory Clinic
Glasgow, Glasgow, United Kingdom
MAC UK Neuroscience Ltd
Blackpool, Lancashire, United Kingdom
Kings College Hospital
London, London, United Kingdom
MAC UK Neuroscience, Research Assessment Centre
Trafford Park, Manchester, United Kingdom
Pollard Park Health Centre
Bradford, , United Kingdom
Clinical Investigation and Research Unit (CIRU)
Brighton, , United Kingdom
Dept. of Neurosciences Charing Cross Hospital
London, , United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Llandough Hospital
Penarth, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Grenoside Grange Hospital
Sheffield, , United Kingdom
Victoria Hospital
Swindon, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2521002
Identifier Type: OTHER
Identifier Source: secondary_id
2007-005995-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3133K1-3001
Identifier Type: -
Identifier Source: org_study_id
NCT00909675
Identifier Type: -
Identifier Source: nct_alias
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