A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
NCT ID: NCT00998764
Last Updated: 2016-01-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
494 participants
INTERVENTIONAL
2009-12-31
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
NCT00996918
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
NCT00676143
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
NCT00667810
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
NCT00574132
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
NCT00937352
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bapineuzumab 0.5 mg/kg
Bapineuzumab 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bapineuzumab 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mini-Mental Status Examination (MMSE) \>=10 at screening
* Caregiver able to attend all clinic visits with subject
Exclusion Criteria
* Any significant brain MRI abnormality.
* Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
51 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Of Alabama at Birmingham
Birmingham, Alabama, United States
UAB Center for Psychiatric Medicine
Birmingham, Alabama, United States
University of Alabama at Birmingham
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
Banner Good Samaritan Medical Center (Imaging
Phoenix, Arizona, United States
Jeffrey S. Gitt
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Associated Neurologist, 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 Infusion Center, Greenwich Hospital
Greenwich, Connecticut, United States
Center for Healthy Aging, Greenwich Hospital
Greenwich, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Medical Specialists 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, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Neurostudies, Inc
Port Charlotte, Florida, United States
Southwest Florida Infusion Care, Inc.
Port Charlotte, Florida, United States
Roskamp Institute
Sarasota, Florida, United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Neuroscience Research Institute, LLC
Lawrenceville, Georgia, United States
Neurostudies.net
Lawrenceville, Georgia, United States
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States
Southern Illinois University School of Medicine Department
Springfield, Illinois, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Neurological Research Center of 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
Alzheimer's Research Corp./Merician Institute for Aging
Paterson, New Jersey, United States
Toms River X-Ray, CT & MRI
Toms River, New Jersey, United States
MDR
Liverpool, New York, 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 Unviersity
Columbus, Ohio, United States
Summit Research Network(Oregon) Inc.
Portland, Oregon, United States
Providence Brain Institute-Cognitive Assessment Clinic
Portland, Oregon, United States
Providence Brain Institute
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Abington Neurological Assoc
Abington, Pennsylvania, United States
Bington Memorial Hospital
Abington, Pennsylvania, United States
Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
East 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
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, LLC
San Antonio, Texas, United States
Vista Infusions
San Antonio, Texas, United States
Inventive Infusion Solutions
San Antonio, Texas, United States
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Gosford Hospital; Pharmacy Dept
Gosford, New South Wales, Australia
Hornsby Hospital
Hornsby, New South Wales, Australia
Royal Adelaide Memory Trials Centre
Adelaide, South Australia, Australia
Memory Unit 5C, Department of Neurology
Woodville South, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia
Hollywood Hospital; Pharmacy Dept
Nedlands, Western Australia, Australia
The McCusker Foundation for Alzheimer's Disease Research
Nedlands, Western Australia, Australia
ZNA Middelheim
Antwerp, , Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, , Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare, , Belgium
Psicomedica Research Group
Santiago, Chile, Chile
Ita-Suomen Yliopisto
Kuopio, , Finland
University of Turku/CRST
Turku, , Finland
CHU de Dijon
Dijon, France, France
Hôpital Roger Salengro
Lille, France, France
Hôpital Pitié-Salpétrière
Paris, France, France
CHU Hôpital Pellegrin-Tripode
Bordeaux, , France
Hopital Neurologique
Bron, , France
CHU de Caen
Caen, , France
Hôpitaux Civils de Colmar
Colmar, , France
Hôpital la Timone
Marseille, , 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
Nice, , France
CHU La Milétrie
Poitiers, , France
C.H.U de Reims
Reims, , France
Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou
Rennes, , France
CHRU Hôtel Dieu
Rennes, , France
Centre Hospitalier Universitaire Charles Nicolle
Rouen, , France
Hôpital Purpan
Toulouse, , France
CHU Purpan - Hôpital Casselardit
Toulouse, , France
Sezione di Neurologia - Dipartimento di Neuroscienze
Ancona, , Italy
Dipartimento di Neuroscienze,
Catania, , Italy
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milan, , Italy
Unita' Operativa C - Riabilitazione Neurologica
Roma, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 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
Kagawa University Hospital
Kagawa, , Japan
Nippon Medical School Musashi Kosugi 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
Okayama University Hospital
Okayama, , Japan
National Hospital Organization Minami-Okayama Medical Center
Okayama, , Japan
Osaka City University Hospital
Osaka, , Japan
Kansai Medical University Takii Hospital
Osaka, , 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
National Hospital Organization Tokyo National Hospital
Tokyo, , Japan
Geriatry
's-Hertogenbosch, , Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
The Memory Clinic Limited
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Signet Research
Christchurch, , New Zealand
NZOZ Neuro-kard
Poznan, Poland, Poland
Pallmed Spolka z o.o.
Bydgoszcz, , Poland
MCD Voxel
Poznan, , Poland
Pracownia Rezonansu Magnetycznego
Warsaw, , Poland
SP ZOZ Szpital Wolski
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Hospitais Da Universidade De Coimbra
Coimbra, Coimbra District, Portugal
Hospital Fernando da Fonseca
Amadora, Lisbon District, Portugal
Hospital Santa Maria
Lisbon, Lisbon District, Portugal
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, , Slovakia
Boithuso Caregivers
Johannesburg, Gauteng, South Africa
The Osteoporosis and Memory Centre
Johannesburg, Gauteng, South Africa
St Augustine's Medical Centre 2
Durban, KwaZulu-Natal, 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
Fundacio ACE Institut Catala de Neurociences Aplicades
Barcelona, Barcelona, Spain
Clinica CIMA
Barcelona, Barcelona, Spain
Hospital Mutua de Terrasa
Terrassa, Barcelona, Spain
Hospital Divino Valles
Burgos, Burgos, Spain
Hospital Virgen del Puerto
Plasencia, Caceres, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Malmo University Hospital
Malmo, , Sweden
Minnes- och geriatrikmottagningen
Uppsala, , Sweden
Memory Clinic Neuro-Psychologie Zentrum
Basel, Canton of Basel-City, Switzerland
Memory Service North, Grenoside Grange Hospital
Grenoside, Sheffield, United Kingdom
Llandough Hospital, Universtity Hospital of Wales
Cardiff, Wales, United Kingdom
MAC UK Neuroscience Ltd.
Bradford, , United Kingdom
Clinical Investigation and Research Unit (CIRU)
Brighton, , United Kingdom
Glasgow Memory Clinic
Glasgow, , United Kingdom
Dept. of Neurosciences Charing Cross Hospital
London, , United Kingdom
The Doctors Laboratory Ltd.
London, , United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Victoria Hospital
Swindon, , United Kingdom
Alliance Medical
Wakefield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B2521004
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015080-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3133K1-3003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.