Study 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.
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers
3 other identifiers
interventional
901
25 countries
343
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Jun 2008
Longer than P75 for phase_3 alzheimer-disease
343 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
January 8, 2016
CompletedJanuary 8, 2016
December 1, 2015
4.3 years
April 24, 2008
October 22, 2013
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
78 weeks
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.
78 weeks
Secondary Outcomes (15)
The Change From Baseline in Brain Amyloid Burden at Week 71.
71 Weeks
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
71 Weeks
The Change From Baseline in Brain Volume at Week 71
71 Weeks
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
39 Weeks
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
39 weeks
- +10 more secondary outcomes
Study Arms (3)
Bapineuzumab 0.5 mg/kg
EXPERIMENTALBapineuzumab 1.0 mg/kg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (346)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Jeffrey S. Gitt, DO, PC
Phoenix, Arizona, 85032, United States
The Compounding Center (IP Mixing Only)
Phoenix, Arizona, 85032, United States
Hope Research Institute
Phoenix, Arizona, 85050, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
ATP Clinical Research, Incorporated
Costa Mesa, California, 92626, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Infusion Care Pharmacey
Laguna Hills, California, 92653, United States
Senior Clinical Trials, Incorporated
Laguna Hills, California, 92653, United States
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Coordinated Clinical Research
San Diego, California, 92103, United States
LabCorp
San Diego, California, 92103, United States
Sharp and Children's MRI Center, LLC
San Diego, California, 92123, United States
Sharp Infusion Therapy Center
San Diego, California, 92123, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, 80304, United States
Associated Neurologists, PC
Boulder, Colorado, 80304, United States
The Mile High Research Center
Denver, Colorado, 80218, United States
Associated Neurologists, PC
Danbury, Connecticut, 06810, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, 06824, United States
Bendheim Cancer Center
Greenwich, Connecticut, 06830, United States
Center for Healthy Aging
Greenwich, Connecticut, 06830, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06511, United States
Norman S. Werdiger, MD
New Haven, Connecticut, 06519, United States
Institutional Review Board / Ethics Committee
New Haven, Connecticut, 06520, United States
Yale PET Center
New Haven, Connecticut, 06520, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
JEM Research Institute LLC
Atlantis, Florida, 33462, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462, United States
Bradenton Research Center, Incorporated
Bradenton, Florida, 34205, United States
North Broward Medical Center
Deerfield Beach, Florida, 33064, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, 33308, United States
MD Clinical
Hallandale, Florida, 33009, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Advanced Imaging
Ocala, Florida, 34481, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410, United States
Neurostudies Inc
Port Charlotte, Florida, 33952, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
South Bay Internal Medicine
Sun City, Florida, 33573, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
NeuroTrials Research, Incorporated
Atlanta, Georgia, 30342, United States
Columbus Diagnostic Center (MRI)
Columbus, Georgia, 31901, United States
Medical Research and Health Education Foundation, Incorporated
Columbus, Georgia, 31909, United States
Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
Decatur, Georgia, 30033, United States
NeuroStudies.net
Decatur, Georgia, 30033, United States
Neurostudies.net
Lawerenceville, Georgia, 30045, United States
Neurostudies.net
Lawrenceville, Georgia, 30046, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007, United States
Methodist Center for Senior Health
Peoria, Illinois, 61602, United States
Methodist Medical Center Research Department
Peoria, Illinois, 61602, United States
Methodist Diagnostic Center
Peoria, Illinois, 61606, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514, United States
Psychology Associates
Mishawaka, Indiana, 46545, United States
KU - Wichita
Wichita, Kansas, 67207, United States
Drug Shipment/ Storage
Wichitia, Kansas, 67205, United States
Four Rivers Clinical Research, Incorporated
Paducah, Kentucky, 42003, United States
Radio Pharmacy
Paducah, Kentucky, 42003, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana Research Associates Inc
New Orleans, Louisiana, 70114, United States
James Gary Booker, MD, APMC
Shreveport, Louisiana, 71104, United States
Foers Medical Arts Pharmacy
Bethesda, Maryland, 20814, United States
CBH Health, LLC
Rockville, Maryland, 20850, United States
Massachusetts General Hospital
Boston, Massachusetts, 021147, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Bringham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University
Boston, Massachusetts, 02118, United States
General Clinical Research Center
Boston, Massachusetts, 02118, United States
IDS Pharmacy
Boston, Massachusetts, 02118, United States
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, 01830, United States
Neurocare, Incorporated
Newton, Massachusetts, 02459, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5872, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
University of Michigan Health System
Ann Arbor, Michigan, 48110, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Michigan State University
Lansing, Michigan, 48910, United States
Marty's Pharmacy
Flowood, Mississippi, 39232, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Spectrum Home Solutions
Great Falls, Montana, 59405, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Alzheimer's Research Corporation
Paterson, New Jersey, 08759, United States
Memory Enhancement Center of New Jersey, Inc.
Toms River, New Jersey, 08755, United States
Northeast Radiology
Brewster, New York, 10509, United States
Neurological Care of Central New York
Liverpool, New York, 13088, United States
AD-CARE, University of Rochester Medical Center
Rochester, New York, 14620, United States
University of Rochester/Strong Memorial Hospital
Rochester, New York, 14642, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, 28803, United States
Alzheimer's Memory Center
Charlotte, North Carolina, 28211, United States
Clinical Trials of America, Incorporated
Hickory, North Carolina, 28601, United States
The Compounding Pharmacy
Hickory, North Carolina, 28602, United States
Carolina Neuropsychological Services, Inc.
Raleigh, North Carolina, 27607, United States
Healthsouth Blue Ridge Surgery Center
Raleigh, North Carolina, 27607, United States
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607, United States
Wake Radiology Associates
Raleigh, North Carolina, 27607, United States
Ohio State University Imaging at Martha Morehouse
Columbus, Ohio, 43210, United States
The Ohio State University Hospitals Clinic
Columbus, Ohio, 43210, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Professional Corporation of Psychiatry
Oklahoma City, Oklahoma, 73112, United States
Red River Medical Recearch Center, LLC
Oklahoma City, Oklahoma, 73112, United States
Flourish Integrative Pharmacy
Oklahoma City, Oklahoma, 73134, United States
Providence Brain Institute
Portland, Oregon, 97225, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, 19104, United States
Hospital of the University of Pennsylvania (PET)
Philadelphia, Pennsylvania, 19104, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Investigational New Drug Services, IDS Pharmacy
Philadelphia, Pennsylvania, 19104, United States
Penn Memory Center
Philadelphia, Pennsylvania, 19104, United States
UPENN Clinical and Translational Research Center (CTRC)
Philadelphia, Pennsylvania, 19104, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914, United States
Simpson's Pharmacy
Pawtucket, Rhode Island, 02861, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, 29425, United States
Medical University of South Carolina Investigational Drug Service
Charleston, South Carolina, 29425, United States
Radiant Research, Incorporated
Greer, South Carolina, 29651, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
Neurology Clinic, PC
Cordova, Tennessee, 38018, United States
Austin Infusion Centers
Austin, Texas, 78756, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Texas Neurology, P.A.
Dallas, Texas, 75214, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Integra Clinical Research, LLC
San Antonio, Texas, 78231, United States
Vista Infusions
San Antonio, Texas, 78231, United States
Inventive Infusion Solutions
San Antonio, Texas, 78258, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Southwestern Vermont Healthcare
Bennington, Vermont, 05201, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
University of Virginia Neurology
Charlottesville, Virginia, 22903, United States
University of Virginia General Clinical Research Center
Charlottesville, Virginia, 22908, United States
University of Viriginia Investigational Pharmacy
Charlottesville, Virginia, 22908, United States
Pacific Medical Centers
Bothell, Washington, 98021, United States
Pacific Medical Centers
Seattle, Washington, 98144, United States
Cemic University Hospital
Buenos Aires, 1431, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Hornsby Kuringai Hospital
Hornsby, New South Wales, 02077, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
CDAMS Ballarat Base Hospital
Ballarat, Victoria, 3353, Australia
Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
West Heidelberg, Victoria, 3081, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
McCusker Alzheimer's Research Foundation Inc.
Nedlands, Western Australia, 6009, Australia
Royal Adelaide Hospital
Adelaide SA, 5000, Australia
ZNA Middelheim / Neurologie
Antwerp, 2020, Belgium
Az. St. Jan Ruddershove 35
Bruges, 8000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
University Hospital Gathuisberg
Leuven, 3000, Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare, 8800, Belgium
Centre for Memory and Aging
North York, Ontario, M6M 3Z5, Canada
Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Centre de Recherche ADAPRA Inc.
L'Ancienne-Lorette, Quebec, G2E 2X1, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Recherche Clinique de Neurologie
Montreal, Quebec, H1T 2M4, Canada
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Psicomedica Research Group
Santiago, Chile, 7530193, Chile
Especialidades Medicas L&S
Santiago, Chile
Sestre milosrdnice Zagreb
Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Turku University Hospital
Turku, Finland, 20520, Finland
Ita-Suomen Yliopisto
Kuopio, FIN-70210, Finland
CHRU Hôtel Dieu
Rennes, Cedex, 35064, France
CHU de Dijon
Dijon, France, 21000, France
CHU Hopital Nord
Amiens, 80054, France
Hôpital Neurologique
Bron, 69677, France
CHU de Caen
Caen, 14033, France
Hôpitaux Civils de Colmar
Colmar, 68024, France
Hôpital Roger Salengro
Lille, 59037, France
Hopital Sainte Marguerite
Marseille, 13009, France
Hôpital la Timone
Marseille, 13885, France
CHU Hôpital Gui de Chaulliac
Montpellier, 34295, France
CHU Nord - Hôpital Guillaume et René Laënnec
Nantes - Saint Herblain, 44093, France
Hôpital Cimiez
Nice, 06000, France
Groupe Hospitalier Broca-La Rochefoucauld
Paris, 75013, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651, France
CHU La Milétrie
Poitiers, 86021, France
C.H.U de Reims
Reims, 51000, France
CHU - Hopital Charles Nicolle
Rouen, 76031, France
Hôpital Purpan
Toulouse, 31059, France
CHU Purpan - Hôpital Casselardit
Toulouse, 31300, France
Klinik fur Psychiatrie und Psychotherapie
Berlin, State of Berlin, 14050, Germany
St. Josef-Klinikum
Bochum, 44791, Germany
Ortenau Klinikum
Offenburg, 77654, Germany
Universitaet Regensburg
Regensburg, 93053, Germany
Universita Politecnica delle Marche
Ancona, 60020, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Unita' Operativa Complessa di Neurologia
Catania, 95126, Italy
CeSI (Centro di Scienze dell'invecchiamento) -
Chieti, 66013, Italy
Universita degli Studi di Firenze
Florence, 50131, Italy
Ospedale S. Raffaele
Milan, 20127, Italy
Ospedale S. Raffaele
Milan, 20132, Italy
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
Monza, 20052, Italy
Ospedale S. Gerardo
Monza, 20052, Italy
Clinica Neurologica
Roma, 00128, Italy
Unita' Operativa C - Riabilitazione Neurologica
Roma, 00179, Italy
Universita degli Studi di Siena
Siena, 53100, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
Ōta-ku, Tokyo, 145-0065, Japan
Yachiyo Hospital
Aichi, 446-8510, Japan
Kashiwado Hospital
Chiba, 260-8656, Japan
National Hospital Organization Chiba-East Hospital
Chiba, 260-8712, Japan
Nippon Medical School Chiba Hokusoh Hospital
Chiba, 270-1694, Japan
National Hospital Organization Kokura Medical Center
Fukuoka, 802-8533, Japan
Maebashi Red Cross Hospital
Gunma, 371-0014, Japan
Gunma University Hospital
Gunma, 371-8511, Japan
Shinozuka Hospital
Gunma, 375-0017, Japan
National Hospital Organization Hiroshima-nishi Medical Ctr.
Hiroshima, 739-0696, Japan
Kobe University Hospital
Hyōgo, 650-0017, Japan
Nishi-Kobe Medical Center
Hyōgo, 651-2273, Japan
Kobe City Hospital Org Kobe City Medical Cente West Hp
Hyōgo, 653-0013, Japan
Kagawa University Hospital
Kagawa, 761-0793, Japan
Nippon Medical School Musashikosugi Hospital
Kanagawa, 211-8533, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Shonan Atsugi Hospital
Kanagawa, 243-8551, Japan
Rakuwakai Otowa Hospital
Kyoto, 607-8062, Japan
National Hospital Organization Minami-Kyoto Hospital
Kyoto, 610-0113, Japan
National Hospital Organization Maizuru Medical Center
Kyoto, 625-8502, Japan
National Hospital Organization Matsumoto Medical Center
Nagano, 399-0021, Japan
National Hospital Organization Niigata National Hospital
Niigata, 945-8585, Japan
Iwate Medical University Hospital
Numakunai, 020-8505, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
National Hospital Organization Minami-Okayama Medical Center
Okayama, 701-0304, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Kansai Medical University Takii Hospital
Osaka, 570-8507, Japan
National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
Shizuoka, 420-8688, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, 136-0075, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, 193-0944, Japan
National Hospital Organization Tokyo National Hospital
Tokyo, 204-8585, Japan
OCA Hospital
Monterrey, Nuevo León, 64000, Mexico
Instituto Biomedico de Investigacion A.C
Aguascalientes, 20127, Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Kennemer Gasthuis
Haarlem, 2035 RC, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
The Memory Clinic
Auckland, NZ, 0622, New Zealand
Signet Research
Christchurch, 8014, New Zealand
Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
Krakow, Poland, 31-531, Poland
NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
Poznan, Poland, 61-289, Poland
NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
Bydgoszcz, 85-796, Poland
NZOZ "SYNAPSA", ul. Niska 5/1
Kielce, 25-317, Poland
Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
Warsaw, 01-211, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
Warsaw, 02-097, Poland
Hospital Fernando da Fonseca
Amadora, Amadora, 2700-276, Portugal
Hospitais Da Universidade De Coimbra
Coimbra, Coimbra District, 3000-075, Portugal
Hospital Santa Maria
Lisbon, Lisbon District, 1649-028, Portugal
Interregional clinicodiagnostic center
Kazan', 420101, Russia
Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
Nizhny Novgorod, 603126, Russia
Saint-Petersburg State institution of healthcare, City geriatric medico-social center
Saint Petersburg, 190103, Russia
Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
Saint Petersburg, 192019, Russia
Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
Saint Petersburg, 192019, Russia
Chair of nervous system diseases
Saint Petersburg, 194044, Russia
Klinicki centar Vojvodine
Novi Sad, Vojvodina, 21000, Serbia
Klinicki centar Srbije
Belgrade, 11000, Serbia
Clinical Centre Kragujevac
Kragujevac, 34000, Serbia
1. Neurologicka klinika
Bratislava, 813 69, Slovakia
Psychiatricka ambulancia
Bratislava, 820 07, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, 825 56, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, 826 06, Slovakia
Neurologicka klinika
Martin, 036 59, Slovakia
Psychiatricka nemocnica Michalovce, n.o.
Michalovce, 071 01, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12, Slovakia
Neurologicke oddelenie FNsP Zilina
Žilina, 012 07, Slovakia
Boithuso Caregivers
Johannesburg, Gauteng, 1709, South Africa
The Osteoporosis and Memory Centre
Johannesburg, Gauteng, 2196, South Africa
Denmar Clinic
Pretoria, Gauteng, 0081, South Africa
St Augustine's Medical Centre 2
Durban, KwaZulu-Natal, 4001, South Africa
Panorama Psychiatry and Memory Clinic
Panorama, Western Cape, 7505, South Africa
Seoul National University Bundang Hospital, Department of Psychiatry
Seongnam-si, Gyeonggi-do, 463-707, South Korea
KonKuk University Hospital, Department of NeuroPsychiatry
Seoul, 143-729, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
CLONUS
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Clínica CIMA
Barcelona, Barcelona, 08034, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
Hospital Mutua de Terrasa
Terrassa, Barcelona, 08221, Spain
Hospital Divino Valles
Burgos, Burgos, 09006, Spain
Hospital Virgen del Puerto
Plasencia, Caceres, 10600, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Fundació ACE Institut Catala de Neurociences Aplicades
Barcelona, 08029, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Skanes Universitetssjukhus, Neuropsykiatriska
Malmo, 21 224, Sweden
PET center
Uppsala, 751 09, Sweden
The clinic: Minnes- och geriatrikmottagningen
Uppsala, 751 85, Sweden
MRI Dept: ORKI
Uppsala, 75185, Sweden
Memory Clinic Neuro-Psychologie Zentrum
Basel, Canton of Basel-City, CH-4031, Switzerland
Hopitaux Universitaires de Geneve
Les Acacias, Canton of Geneva, 1227, Switzerland
CHUV Lausanne
Lausanne, Canton of Vaud, 1005, Switzerland
Hopitaux Universitaires de Geneve
Thonex-Geneva, CH-1226, Switzerland
Glasgow Memory Clinic
Glasgow, Glasgow, G20 0XA, United Kingdom
MAC UK Neuroscience Ltd
Blackpool, Lancashire, FY2 0JH, United Kingdom
Kings College Hospital
London, London, SE5 9RS, United Kingdom
MAC UK Neuroscience, Ltd.
Bradford, West Yorkshire, BD3 0DQ, United Kingdom
Clinical Investigation and Research Unit (CIRU)
Brighton, BN2 5BE, United Kingdom
Dept. of Neurosciences Charing Cross Hospital
London, W6 8RF, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, NE4 5PL, United Kingdom
Northampton General Hospital NHS Trust
Northampton, NN1 5BD, United Kingdom
Llandough Hospital
Penarth, CF64 2XX, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Grenoside Grange Hospital
Sheffield, S35 8QS, United Kingdom
Kingshill Research Centre
Swindon, SN3 6BW, United Kingdom
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: 27176461DERIVEDLacey 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: 26297092DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The impact of study termination, the shorter observational periods and the resulting small sample size coupled with not having enough participants with post baseline assessments for various reasons were limiting factors for data interpretation.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
April 24, 2008
First Posted
April 28, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2012
Study Completion
August 1, 2013
Last Updated
January 8, 2016
Results First Posted
January 8, 2016
Record last verified: 2015-12