Clinical trial NCT00676143: Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
Official title: A Phase Iii, 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 Carriers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: antibody
immunotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 1100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 88
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 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78
timeFrame: Baseline and 78 weeks
measure: Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78
timeFrame: Baseline and 78 weeks
Secondary outcomes:
measure: Change From Baseline in Brain Amyloid Burden at Week 71
timeFrame: Baseline and 71 weeks
measure: Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71
timeFrame: Baseline and 71 Weeks
measure: Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71
timeFrame: Baseline and 71 Weeks
measure: Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
timeFrame: Week 39 to Week 78
measure: Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
timeFrame: Week 39 to Week 78
measure: Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)
timeFrame: Baseline and 78 Weeks
measure: Change From Baseline in Dependence Scale Total Score at Week 78
timeFrame: Baseline and 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)
timeFrame: Baseline and 78 Weeks
measure: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
timeFrame: Baseline and 78 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Center for Psychiatric Medicine
state: Alabama
city: Birmingham
country: United States
facility: Participant and Clinical Interactions Resources
state: Alabama
city: Birmingham
country: United States
facility: UAB Clinical Research Pharmacy-Russell Clinic
state: Alabama
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
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: Carson
country: United States
facility: AC Institute, Incorporated
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc
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: Mile HIgh Research Center
state: Colorado
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: Alzheimer's Disease Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Hospital Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Investigational Drug Service
state: Connecticut
city: New Haven
country: United States
facility: Moshe Hasbani, MD
state: Connecticut
city: New Haven
country: United States
facility: Norman S. Werdiger, MD
state: Connecticut
city: New Haven
country: United States
facility: MR Research Center
state: Connecticut
city: New Haven
country: United States
facility: Yale PET Center
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute, LLC
state: Florida
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Atlantis
country: United States
facility: Medical Specialist of the Palm Beaches
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
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: Tampa
country: United States
facility: University of South Florida
state: Florida
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: Lawrenceville
country: United States
facility: NeuroStudies.net
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine Department
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Univeristy ADCRP
state: Massachusetts
city: Boston
country: United States
facility: General Clincial Research Center (Infusion Location)
state: Massachusetts
city: Boston
country: United States
facility: IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong
state: Massachusetts
city: Dartmouth
country: United States
facility: Shields MRI
state: Massachusetts
city: Pittsfield
country: United States
facility: Neuroscience Research of the Berkshires
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 and Health System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
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: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research P.C.
state: Missouri
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Edison
country: United States
facility: Pharmcare USA
state: New Jersey
city: Manchester
country: United States
facility: Alzheimer's Research Corp./Merician Institute for Aging
state: New Jersey
city: Liverpool
country: United States
facility: Neurological Care of Central New York
state: New York
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
state: North Carolina
city: Raleigh
country: United States
facility: Wake Radiology Associates
state: North Carolina
city: Columbs
country: United States
facility: Ohio State University Imaging@Martha Moorehouse
state: Ohio
city: Columbs
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Summit Research Network(Oregon) Inc.
state: Oregon
city: Portland
country: United States
facility: Providence Brain Institute
state: Oregon
city: Portland
country: United States
facility: Providence Cognitive Assessment Clinic
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Silverton
country: United States
facility: Dr. Michael Gabe (Clinic)
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hosptial
state: Pennsylvania
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Abington
country: United States
facility: Abington Neurological Assoc
state: Pennsylvania
city: Flourtown
country: United States
facility: Andorra MRI of Flourtown
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
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
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania-Penn Memory Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPENN Clinical and Transitional Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital for Neuroscience
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
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
state: South Carolina
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Texas Neurology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
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: San Antonio
country: United States
facility: Inventive Infusions Solutions
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Bennington
country: United States
facility: The Pharmacy
state: Vermont
city: Madison
country: United States
facility: Waisman Center (PET only)
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Madison
country: United States
facility: Wm S. Middleton Memorial Veterans Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto Medico Congreso
city: Buenos Aires
country: Argentina
facility: Cemic University Hospital
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Cordoba
country: Argentina
facility: Instituto Kremer
city: Gosford
country: Australia
facility: Gosford Hospital; Pharmacy Dept
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Hornsby
country: Australia
facility: Hornsby Kuringai Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
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
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Hospital; Pharmacy Dept
state: Western Australia
city: Nedlands
country: Australia
facility: McCusker Alzheimer's Research Foundation, Inc.
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Wien
country: Austria
facility: Allg. Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: SZ Sued - Kaiser-Franz-Josef-Spital
city: Wien
country: Austria
facility: Donauspital
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: Az. St. Jan Ruddershove 35
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen
city: Santiago
country: Chile
facility: Psicomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Medicas LyS
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Kuopio
country: Finland
facility: Ita-Suomen Yliopisto
city: Turku
country: Finland
facility: University of Turku / CRST
city: Bordeaux Cedex
country: France
facility: CHU Pellegrin
city: Bron
country: France
facility: Hopital neurologique du Pr A. Vighetto
city: Caen
country: France
facility: Centre d'Imagerie medicale de Basse Normandie
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: CHRU de Lille
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 C.M.R.R.
city: Nice
country: France
facility: Service d'Imagerie Medicale
city: Paris
country: France
facility: Groupe Hospitalier Broca-La Rochefoucauld
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Poitiers
country: France
facility: Hospital Jean Bernard CIC
city: Reims
country: France
facility: C.H.U de Reims
city: Rennes Cedex
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU - Hopital Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Purpan
city: Toulouse
country: France
facility: CHU Toulouse - Site Casselardit
city: Berlin
country: Germany
facility: Charite-Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: St. Josef-Klinikum
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Freiburg
country: Germany
facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg
city: Offenburg
country: Germany
facility: Ortenau Klinikum Offenburg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Ancona
country: Italy
facility: A.O. Umberto I
city: Ancona
country: Italy
facility: Sezione di Neurologia - Dipartimento di Neuroscienze
city: Brescia
country: Italy
facility: Clinica Neurologica - II Neurologia
city: Catania
country: Italy
facility: Dipartimento di Neuroscienze,
city: Catania
country: Italy
facility: Unita' Operativa Complessa di Neurologia
city: Chieti
country: Italy
facility: CeSI (Centro di Scienze dell'invecchiamento) -
city: Milano
country: Italy
facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta
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: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital
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 Musashi Kosugi 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 Metropolitan Health and Med. Treatment Co. Ebara Hosp
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Monterrey
country: Mexico
facility: OCA Hospital
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Instituto Biomedico de Investigacion A.C
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Noord Brabant
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuizen
state: Noord Holland
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
state: The Netherlands
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus MC
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: Krakow
country: Poland
facility: Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i
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: Belgrade
country: Serbia
facility: Klinicki centar Srbije
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Clinic of Psichiatry
city: Novi Sad
country: Serbia
facility: Klinicki Centar Vojvodina
city: Sremska Kamenica
country: Serbia
facility: Diagnostic Imaging Center
city: Sremska Kamenica
country: Serbia
facility: Institute for Cardiovascular Diseases of Vojvodina
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Michalovce
country: Slovakia
facility: Psychiatricka nemocnica Michalovce, n.o.
city: Rimavska Sobota
country: Slovakia
facility: Vseobecna nemocnica Rimavska Sobota
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: Bellville
country: South Africa
facility: Flexivest Fourteen Research Center
state: Western Cape
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 Terrassa
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: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Pais Vasco
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcalla
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundacio ACE Institut Catala de Neurociences Aplicades
city: Barcelona
country: Spain
facility: Centro Internacional de Medicina Avanzda (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 de 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 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: Malmo University Hospital
city: Uppsala
country: Sweden
facility: Uppsala Imanet AB
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Uppsala
country: Sweden
facility: ORKI, enheten for radiologi
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: Trafford Park
country: United Kingdom
facility: MAC UK Neuroscience, Research Assessment Centre
state: Manchester
city: Bradford
country: United Kingdom
facility: Pollard Park Health Centre
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
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: Victoria Hospital
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.