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

NCT00676143 | Terminated Phase 3 Results DMC

• 3 other identifiers: 3133K1-3001B25210022007-005995-14
• Study Type: interventional
• Target: 1,100
• Locations: 22 countries
• Sites: 279

Brief 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.

Conditions

Alzheimer Disease

Keywords

antibody; immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 78 weeks

• 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.

  Baseline and 78 weeks

Secondary Outcomes (15)

• Change From Baseline in Brain Amyloid Burden at Week 71

  Baseline and 71 weeks

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

  Baseline and 71 Weeks

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

  Baseline and 71 Weeks

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

  Week 39 to Week 78

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

  Week 39 to Week 78

Study Arms (2)

Bapineuzumab 0.5 mg/kg

EXPERIMENTAL

Drug: bapineuzumab

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

bapineuzumab DRUG

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

Also known as: AAB-001

Bapineuzumab 0.5 mg/kg

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (288)

Center for Psychiatric Medicine

Birmingham, Alabama, 35294, United States

Location

Participant and Clinical Interactions Resources

Birmingham, Alabama, 35294, United States

Location

UAB Clinical Research Pharmacy-Russell Clinic

Birmingham, Alabama, 35294, United States

Location

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Dedicated Clinical Research

Goodyear, Arizona, 85395, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Jeffrey S. Gitt, DO, PC

Phoenix, Arizona, 85032, United States

Location

The Compounding Center

Phoenix, Arizona, 85032, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

AC Institute, Incorporated

Carson, California, 90746, United States

Location

Collaborative Neuroscience Network, Inc

Long Beach, California, 90806, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Alpine Clinical Research Center, Inc.

Boulder, Colorado, 80304, United States

Location

Associated Neurologists, PC

Boulder, Colorado, 80304, United States

Location

Mile HIgh Research Center

Denver, Colorado, 80218, United States

Location

Associated Neurologists of Southern Connecticut, P.C.

Fairfield, Connecticut, 06824, United States

Location

Bendheim Cancer Center

Greenwich, Connecticut, 06830, United States

Location

Center for Healthy Aging

Greenwich, Connecticut, 06830, United States

Location

Alzheimer's Disease Research Unit

New Haven, Connecticut, 06510, United States

Location

Hospital Research Unit

New Haven, Connecticut, 06510, United States

Location

Investigational Drug Service

New Haven, Connecticut, 06511, United States

Location

Moshe Hasbani, MD

New Haven, Connecticut, 06511, United States

Location

Norman S. Werdiger, MD

New Haven, Connecticut, 06519, United States

Location

MR Research Center

New Haven, Connecticut, 06520, United States

Location

Yale PET Center

New Haven, Connecticut, 06520, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

JEM Research Institute, LLC

Atlantis, Florida, 33462, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Medical Specialist of the Palm Beaches

Atlantis, Florida, 33462, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Palm Beach Neurological Center

Palm Beach Gardens, Florida, 33418, United States

Location

Neurostudies Inc

Port Charlotte, Florida, 33952, United States

Location

Roskamp Institute

Sarasota, Florida, 34243, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

Decatur, Georgia, 30033, United States

Location

Neurostudies.net

Decatur, Georgia, 30033, United States

Location

NeuroStudies.net

Lawrenceville, Georgia, 30045, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Southern Illinois University School of Medicine Department

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Brigham & Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Univeristy ADCRP

Boston, Massachusetts, 02118, United States

Location

General Clincial Research Center (Infusion Location)

Boston, Massachusetts, 02118, United States

Location

IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong

Boston, Massachusetts, 02118, United States

Location

Neuroscience Research of the Berkshires

Pittsfield, Massachusetts, 01201, United States

Location

Shields MRI

Russells Mills, Massachusetts, 02747, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

University of Michigan Hospital and Health System

Ann Arbor, Michigan, 48105-2945, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5872, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48110, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

The Center for Pharmaceutical Research P.C.

Kansas City, Missouri, 64114, United States

Location

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Pharmcare USA

Edison, New Jersey, 08837, United States

Location

Alzheimer's Research Corp./Merician Institute for Aging

Paterson, New Jersey, 08759, United States

Location

Neurological Care of Central New York

Liverpool, New York, 13088, United States

Location

Carolina Neuropsychological Services, Inc

Raleigh, North Carolina, 27607, United States

Location

Healthsouth Blue Ridge Surgery Center

Raleigh, North Carolina, 27607, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Wake Radiology Associates

Raleigh, North Carolina, 27607, United States

Location

Ohio State University Imaging@Martha Moorehouse

Columbs, Ohio, 43210, United States

Location

The Ohio State University

Columbs, Ohio, 43210, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Summit Research Network(Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Providence Brain Institute

Portland, Oregon, 97225, United States

Location

Providence Cognitive Assessment Clinic

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Dr. Michael Gabe (Clinic)

Silverton, Oregon, 97381, United States

Location

Abington Memorial Hosptial

Abington, Pennsylvania, 19001, United States

Location

Abington Neurological Associates

Abington, Pennsylvania, 19001, United States

Location

Abington Neurological Assoc

Abington, Pennsylvania, 19001, United States

Location

Andorra MRI of Flourtown

Flourtown, Pennsylvania, 19031, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational New Drug Services

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania-Penn Memory Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPENN Clinical and Transitional Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Hospital for Neuroscience

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Simpson's Pharmacy

Pawtucket, Rhode Island, 02861, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina Hospitals and Clinics

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Texas Neurology, P.A.

Dallas, Texas, 75214, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Integra Clinical Research

San Antonio, Texas, 78229, United States

Location

Integra Clinical Research, LLC

San Antonio, Texas, 78231, United States

Location

Integra Clinical Research

San Antonio, Texas, 78231, United States

Location

Vista Infusions

San Antonio, Texas, 78231, United States

Location

Inventive Infusion Solutions

San Antonio, Texas, 78258, United States

Location

Inventive Infusions Solutions

San Antonio, Texas, 78258, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

The Pharmacy

Bennington, Vermont, 05201, United States

Location

Waisman Center (PET only)

Madison, Wisconsin, 53705-2280, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

Wm S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Instituto Medico Congreso

Buenos Aires, Buenos Aires, 1090, Argentina

Location

Instituto Medico Congreso

Buenos Aires, 1090, Argentina

Location

Cemic University Hospital

Buenos Aires, 1431, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABD, Argentina

Location

Instituto Kremer

Córdoba, 5004, Argentina

Location

Gosford Hospital; Pharmacy Dept

Gosford, New South Wales, 2250, Australia

Location

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Hornsby Kuringai Hospital

Hornsby, New South Wales, 2077, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

CDAMS Ballarat Base Hospital

Ballarat, Victoria, 3353, Australia

Location

Heidelberg Repatriation Hospital

West Heidelberg, Victoria, 3081, Australia

Location

Hollywood Hospital; Pharmacy Dept

Nedlands, Western Australia, 6009, Australia

Location

McCusker Alzheimer's Research Foundation, Inc.

Nedlands, Western Australia, 6009, Australia

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Landeskrankenhaus Klagenfurt

Klagenfurt, A-9020, Austria

Location

Allg. Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

SZ Sued - Kaiser-Franz-Josef-Spital

Vienna, 1220, Austria

Location

Donauspital

Vienna, A-1220, Austria

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Az. St. Jan Ruddershove 35

Bruges, 8000, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium

Location

H.-Hartziekenhuis Roeselare-Menen

Roeselare, 8800, Belgium

Location

Psicomedica Research Group

Santiago, Chile, 7530193, Chile

Location

Especialidades Medicas LyS

Santiago, Chile

Location

University Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

Ita-Suomen Yliopisto

Kuopio, FIN-70210, Finland

Location

University of Turku / CRST

Turku, 20520, Finland

Location

CHU de Dijon

Dijon, France, 21033, France

Location

CHU Pellegrin

Bordeaux, 33076, France

Location

Hopital neurologique du Pr A. Vighetto

Bron, 69677, France

Location

Centre d'Imagerie medicale de Basse Normandie

Caen, 14000, France

Location

CHU de Caen

Caen, 14033, France

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hôpital la Timone

Marseille, 13385, France

Location

CHU Hôpital Gui de Chaulliac

Montpellier, 34295, France

Location

CHU Nord - Hôpital Guillaume et René Laënnec

Nantes - Saint Herblain, 44093, France

Location

Hôpital Cimiez C.M.R.R.

Nice, 06000, France

Location

Service d'Imagerie Medicale

Nice, 06002, France

Location

Groupe Hospitalier Broca-La Rochefoucauld

Paris, 75013, France

Location

Hôpital Pitié-Salpétrière

Paris, 75651, France

Location

Hospital Jean Bernard CIC

Poitiers, 86000, France

Location

C.H.U de Reims

Reims, 51092, France

Location

CHU de Rennes

Rennes, 35064, France

Location

CHU - Hopital Charles Nicolle

Rouen, 76031, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

CHU Toulouse - Site Casselardit

Toulouse, 31300, France

Location

Charite-Universitätsmedizin Berlin

Berlin, State of Berlin, 14050, Germany

Location

St. Josef-Klinikum

Bochum, 44791, Germany

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Klinikum der Albert-Ludwigs-Universitaet Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Ortenau Klinikum Offenburg

Offenburg, 77654, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

A.O. Umberto I

Ancona, 60020, Italy

Location

Sezione di Neurologia - Dipartimento di Neuroscienze

Ancona, 60020, Italy

Location

Clinica Neurologica - II Neurologia

Brescia, 25123, Italy

Location

Dipartimento di Neuroscienze,

Catania, 95123, Italy

Location

Unita' Operativa Complessa di Neurologia

Catania, 95126, Italy

Location

CeSI (Centro di Scienze dell'invecchiamento) -

Chieti, 66013, Italy

Location

Fondazione IRCCS- Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Ospedale S. Gerardo

Monza, 20052, Italy

Location

Clinica Neurologica

Roma, 00128, Italy

Location

Unita' Operativa C - Riabilitazione Neurologica

Roma, 00179, Italy

Location

Universita degli Studi di Siena

Siena, 53100, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Hospital Organization Tokyo National Hospital

Kiyose, Tokyo, 204-8585, Japan

Location

Yachiyo Hospital

Aichi, 446-8510, Japan

Location

Kashiwado Hospital

Chiba, 260-8656, Japan

Location

National Hospital Organization Chiba-East Hospital

Chiba, 260-8712, Japan

Location

Nippon Medical School Chiba Hokusoh Hospital

Chiba, 270-1694, Japan

Location

National Hospital Organization Kokura Medical Center

Fukuoka, 802-8533, Japan

Location

Maebashi Red Cross Hospital

Gunma, 371-0014, Japan

Location

Gunma University Hospital

Gunma, 371-8511, Japan

Location

Shinozuka Hospital

Gunma, 375-0017, Japan

Location

National Hospital Organization Hiroshima-nishi Medical Ctr.

Hiroshima, 739-0696, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Nishi-Kobe Medical Center

Hyōgo, 651-2273, Japan

Location

Kobe City Hospital Org Kobe City Medical Cente West Hp

Hyōgo, 653-0013, Japan

Location

Kagawa University Hospital

Kagawa, 761-0793, Japan

Location

Nippon Medical School Musashi Kosugi Hospital

Kanagawa, 211-8533, Japan

Location

Yokohama City University Medical Center

Kanagawa, 232-0024, Japan

Location

Shonan Atsugi Hospital

Kanagawa, 243-8551, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, 607-8062, Japan

Location

National Hospital Organization Minami-Kyoto Hospital

Kyoto, 610-0113, Japan

Location

National Hospital Organization Maizuru Medical Center

Kyoto, 625-8502, Japan

Location

National Hospital Organization Matsumoto Medical Center

Nagano, 399-0021, Japan

Location

National Hospital Organization Niigata National Hospital

Niigata, 945-8585, Japan

Location

Iwate Medical University Hospital

Numakunai, 020-8505, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

National Hospital Organization Minami-Okayama Medical Center

Okayama, 701-0304, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Kansai Medical University Takii Hospital

Osaka, 570-8507, Japan

Location

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

Shizuoka, 420-8688, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Juntendo Tokyo Koto Geriatric Medical Center

Tokyo, 136-0075, Japan

Location

Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

Tokyo, 145-0065, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

OCA Hospital

Monterrey, Nuevo León, 64000, Mexico

Location

Instituto Biomedico de Investigacion A.C

Aguascalientes, 20127, Mexico

Location

Amphia Ziekenhuis

Breda, North Brabant, 4818 CK, Netherlands

Location

Tergooi Ziekenhuizen

Hilversum, North Holland, 1213 XZ, Netherlands

Location

Kennemer Gasthuis

Haarlem, The Netherlands, 2035 RC, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

The Memory Clinic

Auckland, NZ, 0622, New Zealand

Location

Signet Research

Christchurch, 8014, New Zealand

Location

Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i

Krakow, Poland, 31-531, Poland

Location

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

Poznan, Poland, 61-289, Poland

Location

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

Bydgoszcz, 85-796, Poland

Location

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

Warsaw, 01-211, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

Warsaw, 02-097, Poland

Location

Hospital Fernando da Fonseca

Amadora, Amadora, 2720-276, Portugal

Location

Hospitais Da Universidade De Coimbra

Coimbra, Coimbra District, 3000-075, Portugal

Location

Hospital Santa Maria

Lisbon, Lisbon District, 1649-028, Portugal

Location

Klinicki centar Srbije

Belgrade, 11000, Serbia

Location

Diagnostic Imaging Center

Kamenitz, 21204, Serbia

Location

Institute for Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Centre Kragujevac, Clinic of Psichiatry

Kragujevac, 34000, Serbia

Location

Klinicki Centar Vojvodina

Novi Sad, 21000, Serbia

Location

Psychiatricka ambulancia

Bratislava, 820 07, Slovakia

Location

Univerzitna nemocnica Bratislava

Bratislava, 825 56, Slovakia

Location

Psychiatricka nemocnica Michalovce, n.o.

Michalovce, 071 01, Slovakia

Location

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 12, Slovakia

Location

Boithuso Caregivers

Johannesburg, Gauteng, 1709, South Africa

Location

The Osteoporosis and Memory Centre

Johannesburg, Gauteng, 2196, South Africa

Location

Denmar Clinic

Pretoria, Gauteng, 0081, South Africa

Location

St Augustine's Medical Centre 2

Durban, KwaZulu-Natal, 4001, South Africa

Location

Flexivest Fourteen Research Center

Bellville, Western Cape, 7530, South Africa

Location

Panorama Psychiatry and Memory Clinic

Panorama, Western Cape, 7500, South Africa

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

CLONUS

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Basque Country, 20014, Spain

Location

Hospital Divino Valles

Burgos, Burgos, 09006, Spain

Location

Hospital Virgen del Puerto

Plasencia, Caceres, 10600, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital de Cruces

Barakaldo, Vizcalla, 48903, Spain

Location

Fundacio ACE Institut Catala de Neurociences Aplicades

Barcelona, 08014, Spain

Location

Centro Internacional de Medicina Avanzda (CIMA)

Barcelona, 08034, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Malmo University Hospital

Malmo, 21 224, Sweden

Location

Uppsala Imanet AB

Uppsala, 751 09, Sweden

Location

Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

ORKI, enheten for radiologi

Uppsala, 75185, Sweden

Location

Memory Clinic Neuro-Psychologie Zentrum

Basel, Canton of Basel-City, CH-4031, Switzerland

Location

Hopitaux Universitaires de Geneve

Les Acacias, Canton of Geneva, 1227, Switzerland

Location

CHUV Lausanne

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Hopitaux Universitaires de Geneve

Thonex-Geneva, CH-1226, Switzerland

Location

Glasgow Memory Clinic

Glasgow, Glasgow, G20 0XA, United Kingdom

Location

MAC UK Neuroscience Ltd

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

Kings College Hospital

London, London, SE5 9RS, United Kingdom

Location

MAC UK Neuroscience, Research Assessment Centre

Trafford Park, Manchester, M32 0UT, United Kingdom

Location

Pollard Park Health Centre

Bradford, BD3 0DQ, United Kingdom

Location

Clinical Investigation and Research Unit (CIRU)

Brighton, BN2 5BE, United Kingdom

Location

Dept. of Neurosciences Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

Llandough Hospital

Penarth, CF64 2XX, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Grenoside Grange Hospital

Sheffield, S35 8QS, United Kingdom

Location

Victoria Hospital

Swindon, SN3 6BW, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27176461 DERIVED

• 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.

  PMID: 26297092 DERIVED

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 12, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 10, 2016
• Results First Posted: June 10, 2016

Record last verified: 2016-05

Locations

AU (9); NZ (2); BE (6); DE (6); FR (20); ZA (6); ES (18); SE (5); CR (1); ME (2); SL (4); CL (2); CH (4); PT (3); US (111); GB (13); PL (5); FI (2); IT (11); JP (35); AR (5); NL (9)