Clinical trial NCT00667810: Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: antibody
immunotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 901
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
timeFrame: 78 weeks
measure: The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
timeFrame: 78 weeks
Secondary outcomes:
measure: The Change From Baseline in Brain Amyloid Burden at Week 71.
timeFrame: 71 Weeks
measure: The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
timeFrame: 71 Weeks
measure: The Change From Baseline in Brain Volume at Week 71
timeFrame: 71 Weeks
measure: Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
timeFrame: 39 Weeks
measure: Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
timeFrame: 39 weeks
measure: Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
timeFrame: 78 Weeks
measure: Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
timeFrame: 78 weeks
measure: Time to Median Placebo Deterioration on DAD Total Score
timeFrame: 78 Weeks
measure: Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
timeFrame: 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
timeFrame: 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
timeFrame: 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
timeFrame: 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
timeFrame: 78 weeks
measure: Change From Baseline in Dependence Scale Total Score at Week 78
timeFrame: 78 Weeks
measure: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
timeFrame: 78 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: Jeffrey S. Gitt, DO, PC
state: Arizona
city: Phoenix
country: United States
facility: The Compounding Center (IP Mixing Only)
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Incorporated
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Laguna Hills
country: United States
facility: Infusion Care Pharmacey
state: California
city: Laguna Hills
country: United States
facility: Senior Clinical Trials, Incorporated
state: California
city: Loma Linda
country: United States
facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Coordinated Clinical Research
state: California
city: San Diego
country: United States
facility: LabCorp
state: California
city: San Diego
country: United States
facility: Sharp and Children's MRI Center, LLC
state: California
city: San Diego
country: United States
facility: Sharp Infusion Therapy Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc.
state: Colorado
city: Boulder
country: United States
facility: Associated Neurologists, PC
state: Colorado
city: Denver
country: United States
facility: The Mile High Research Center
state: Colorado
city: Danbury
country: United States
facility: Associated Neurologists, PC
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, P.C.
state: Connecticut
city: Greenwich
country: United States
facility: Bendheim Cancer Center
state: Connecticut
city: Greenwich
country: United States
facility: Center for Healthy Aging
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Norman S. Werdiger, MD
state: Connecticut
city: New Haven
country: United States
facility: Institutional Review Board / Ethics Committee
state: Connecticut
city: New Haven
country: United States
facility: Yale PET Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute LLC
state: Florida
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Incorporated
state: Florida
city: Deerfield Beach
country: United States
facility: North Broward Medical Center
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Neurologic Consultants, P.A.
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Advanced Imaging
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: Sun City
country: United States
facility: South Bay Internal Medicine
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Incorporated
state: Georgia
city: Columbus
country: United States
facility: Columbus Diagnostic Center (MRI)
state: Georgia
city: Columbus
country: United States
facility: Medical Research and Health Education Foundation, Incorporated
state: Georgia
city: Decatur
country: United States
facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net
state: Georgia
city: Lawerenceville
country: United States
facility: Neurostudies.net
state: Georgia
city: Lawrenceville
country: United States
facility: Neurostudies.net
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosciences Institute
state: Illinois
city: Peoria
country: United States
facility: Methodist Center for Senior Health
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center Research Department
state: Illinois
city: Peoria
country: United States
facility: Methodist Diagnostic Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Mishawaka
country: United States
facility: Psychology Associates
state: Indiana
city: Wichita
country: United States
facility: KU - Wichita
state: Kansas
city: Wichitia
country: United States
facility: Drug Shipment/ Storage
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Incorporated
state: Kentucky
city: Paducah
country: United States
facility: Radio Pharmacy
state: Kentucky
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates Inc
state: Louisiana
city: Shreveport
country: United States
facility: James Gary Booker, MD, APMC
state: Louisiana
city: Bethesda
country: United States
facility: Foers Medical Arts Pharmacy
state: Maryland
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Bringham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Boston
country: United States
facility: General Clinical Research Center
state: Massachusetts
city: Boston
country: United States
facility: IDS Pharmacy
state: Massachusetts
city: Haverhill
country: United States
facility: ActivMed Practices and Research, Inc.
state: Massachusetts
city: Newton
country: United States
facility: Neurocare, Incorporated
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Flowood
country: United States
facility: Marty's Pharmacy
state: Mississippi
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Great Falls
country: United States
facility: Spectrum Home Solutions
state: Montana
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Manchester
country: United States
facility: Alzheimer's Research Corporation
state: New Jersey
city: Toms River
country: United States
facility: Memory Enhancement Center of New Jersey, Inc.
state: New Jersey
city: Brewster
country: United States
facility: Northeast Radiology
state: New York
city: Liverpool
country: United States
facility: Neurological Care of Central New York
state: New York
city: Rochester
country: United States
facility: AD-CARE, University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester/Strong Memorial Hospital
state: New York
city: Asheville
country: United States
facility: Clinical Study Center of Asheville, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, Incorporated
state: North Carolina
city: Hickory
country: United States
facility: The Compounding Pharmacy
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Neuropsychological Services, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Healthsouth Blue Ridge Surgery Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Radiology Associates
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Imaging at Martha Morehouse
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Hospitals Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Professional Corporation of Psychiatry
state: Oklahoma
city: Oklahoma City
country: United States
facility: Red River Medical Recearch Center, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Flourish Integrative Pharmacy
state: Oklahoma
city: Portland
country: United States
facility: Providence Brain Institute
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Jenkintown
country: United States
facility: Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennslyvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania (PET)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational New Drug Services, IDS Pharmacy
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Memory Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPENN Clinical and Translational Research Center (CTRC)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood and Memory Research Institute
state: Rhode Island
city: Pawtucket
country: United States
facility: Simpson's Pharmacy
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina Hospitals and Clinics
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina Investigational Drug Service
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Incorporated
state: South Carolina
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cordova
country: United States
facility: Neurology Clinic, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Infusion Centers
state: Texas
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Vista Infusions
state: Texas
city: San Antonio
country: United States
facility: Inventive Infusion Solutions
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bennington
country: United States
facility: Southwestern Vermont Healthcare
state: Vermont
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Neurology
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia General Clinical Research Center
state: Virginia
city: Charlottesville
country: United States
facility: University of Viriginia Investigational Pharmacy
state: Virginia
city: Bothell
country: United States
facility: Pacific Medical Centers
state: Washington
city: Seattle
country: United States
facility: Pacific Medical Centers
state: Washington
city: Buenos Aires
country: Argentina
facility: Cemic University Hospital
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Hornsby
country: Australia
facility: Hornsby Kuringai Hospital
state: New South Wales
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Ballarat
country: Australia
facility: CDAMS Ballarat Base Hospital
state: Victoria
city: West Heidelberg
country: Australia
facility: Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: McCusker Alzheimer's Research Foundation Inc.
state: Western Australia
city: Adelaide SA
country: Australia
facility: Royal Adelaide Hospital
city: Antwerpen
country: Belgium
facility: ZNA Middelheim / Neurologie
city: Brugge
country: Belgium
facility: Az. St. Jan Ruddershove 35
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: University Hospital Gathuisberg
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen
city: North York
country: Canada
facility: Centre for Memory and Aging
state: Ontario
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: L'Ancienne-Lorette
country: Canada
facility: Centre de Recherche ADAPRA Inc.
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Recherche Clinique de Neurologie
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Santiago
country: Chile
facility: Psicomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Medicas L&S
city: Zagreb
country: Croatia
facility: Sestre milosrdnice Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Kuopio
country: Finland
facility: Ita-Suomen Yliopisto
city: Turku
country: Finland
facility: Turku University Hospital
city: Rennes
country: France
facility: CHRU Hôtel Dieu
state: Cedex
city: Amiens
country: France
facility: CHU Hopital Nord
city: Bron
country: France
facility: Hôpital Neurologique
city: Caen
country: France
facility: CHU de Caen
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Marseille
country: France
facility: Hopital Sainte Marguerite
city: Marseille
country: France
facility: Hôpital la Timone
city: Montpellier
country: France
facility: CHU Hôpital Gui de Chaulliac
city: Nantes - Saint Herblain
country: France
facility: CHU Nord - Hôpital Guillaume et René Laënnec
city: Nice
country: France
facility: Hôpital Cimiez
city: Paris Cedex 13
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Paris
country: France
facility: Groupe Hospitalier Broca-La Rochefoucauld
city: Poitiers
country: France
facility: CHU La Milétrie
city: Reims
country: France
facility: C.H.U de Reims
city: Rouen
country: France
facility: CHU - Hopital Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Purpan
city: Toulouse
country: France
facility: CHU Purpan - Hôpital Casselardit
city: Berlin
country: Germany
facility: Klinik fur Psychiatrie und Psychotherapie
city: Bochum
country: Germany
facility: St. Josef-Klinikum
city: Offenburg
country: Germany
facility: Ortenau Klinikum
city: Regensburg
country: Germany
facility: Universitaet Regensburg
city: Ancona
country: Italy
facility: Universita Politecnica delle Marche
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: Unita' Operativa Complessa di Neurologia
city: Chieti
country: Italy
facility: CeSI (Centro di Scienze dell'invecchiamento) -
city: Firenze
country: Italy
facility: Universita degli Studi di Firenze
city: Milano
country: Italy
facility: Ospedale S. Raffaele
city: Milano
country: Italy
facility: Ospedale S. Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Roma
country: Italy
facility: Clinica Neurologica
city: Roma
country: Italy
facility: Unita' Operativa C - Riabilitazione Neurologica
city: Siena
country: Italy
facility: Universita degli Studi di Siena
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi,
city: Ota-ku
country: Japan
facility: Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
state: Tokyo
city: Aichi
country: Japan
facility: Yachiyo Hospital
city: Chiba
country: Japan
facility: Kashiwado Hospital
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East Hospital
city: Chiba
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kokura Medical Center
city: Gunma
country: Japan
facility: Maebashi Red Cross Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Gunma
country: Japan
facility: Shinozuka Hospital
city: Hiroshima
country: Japan
facility: National Hospital Organization Hiroshima-nishi Medical Ctr.
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Hyogo
country: Japan
facility: Nishi-Kobe Medical Center
city: Hyogo
country: Japan
facility: Kobe City Hospital Org Kobe City Medical Cente West Hp
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kanagawa
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Shonan Atsugi Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Minami-Kyoto Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Maizuru Medical Center
city: Nagano
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Niigata
country: Japan
facility: National Hospital Organization Niigata National Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Minami-Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Takii Hospital
city: Shizuoka
country: Japan
facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo National Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Department of Psychiatry
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: KonKuk University Hospital, Department of NeuroPsychiatry
city: Monterrey
country: Mexico
facility: OCA Hospital
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Instituto Biomedico de Investigacion A.C
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: s. Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Auckland
country: New Zealand
facility: The Memory Clinic
state: NZ
city: Christchurch
country: New Zealand
facility: Signet Research
city: Bydgoszcz
country: Poland
facility: NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
city: Kielce
country: Poland
facility: NZOZ "SYNAPSA", ul. Niska 5/1
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
city: Poznan
country: Poland
facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
city: Warszawa
country: Poland
facility: Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
city: Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Coimbra
country: Portugal
facility: Hospitais Da Universidade De Coimbra
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Kazan
country: Russian Federation
facility: Interregional clinicodiagnostic center
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State institution of healthcare, City geriatric medico-social center
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
city: Saint-Petersburg
country: Russian Federation
facility: Chair of nervous system diseases
city: Novi Sad
country: Serbia
facility: Klinicki centar Vojvodine
state: Vojvodina
city: Belgrade
country: Serbia
facility: Klinicki centar Srbije
city: Beograd
country: Serbia
facility: Klinicki centar Srbije
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac
city: Bratislava
country: Slovakia
facility: 1. Neurologicka klinika
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Martin
country: Slovakia
facility: Neurologicka klinika
city: Michalovce
country: Slovakia
facility: Psychiatricka nemocnica Michalovce, n.o.
city: Rimavska Sobota
country: Slovakia
facility: Vseobecna nemocnica Rimavska Sobota
city: Zilina
country: Slovakia
facility: Neurologicke oddelenie FNsP Zilina
city: Johannesburg
country: South Africa
facility: Boithuso Caregivers
state: Gauteng
city: Johannesburg
country: South Africa
facility: The Osteoporosis and Memory Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Denmar Clinic
state: Gauteng
city: Durban
country: South Africa
facility: St Augustine's Medical Centre 2
state: Kwa Zulu Natal
city: Panorama
country: South Africa
facility: Panorama Psychiatry and Memory Clinic
state: Western Cape
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrasa
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto
state: Caceres
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Palma de Mallorca
country: Spain
facility: CLONUS
state: Islas Baleares
city: Baracaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundació ACE Institut Catala de Neurociences Aplicades
city: Barcelona
country: Spain
facility: Clínica CIMA
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Burgos
country: Spain
facility: Hospital Divino Valles
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus, Neuropsykiatriska
city: Uppsala
country: Sweden
facility: PET center
city: Uppsala
country: Sweden
facility: The clinic: Minnes- och geriatrikmottagningen
city: Uppsala
country: Sweden
facility: MRI Dept: ORKI
city: Basel
country: Switzerland
facility: Memory Clinic Neuro-Psychologie Zentrum
state: BS
city: Les Acacias
country: Switzerland
facility: Hopitaux Universitaires de Geneve
state: GE
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
state: VD
city: Thonex-Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Blackpool
country: United Kingdom
facility: MAC UK Neuroscience Ltd
state: Lancashire
city: Bradford
country: United Kingdom
facility: MAC UK Neuroscience, Ltd.
state: West Yorkshire
city: Brighton
country: United Kingdom
facility: Clinical Investigation and Research Unit (CIRU)
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Dept. of Neurosciences Charing Cross Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
city: Penarth
country: United Kingdom
facility: Llandough Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Sheffield
country: United Kingdom
facility: Grenoside Grange Hospital
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.