Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667810
• Other study ID #: 3133K1-3000
• Secondary ID: B25210012007-005
• Status: Terminated
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: December 4, 2015
• Start date: June 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00909623

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 901
• Est. completion date: August 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
• bapineuzumab
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
• placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Croatia,  Finland,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	The Change From Baseline in Brain Amyloid Burden at Week 71.	Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.	71 Weeks	No
Secondary	The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.	Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.	71 Weeks	No
Secondary	The Change From Baseline in Brain Volume at Week 71	Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.	71 Weeks	No
Secondary	Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78	The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.	39 Weeks	No
Secondary	Divergence of Effect on the DAD Total Scores From Week 39 to Week 78	The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.	39 weeks	No
Secondary	Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)	The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.	78 Weeks	No
Secondary	Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)	The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.	78 weeks	No
Secondary	Time to Median Placebo Deterioration on DAD Total Score	The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.	78 Weeks	No
Secondary	Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)	The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.	78 Weeks	No
Secondary	Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)	Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.	78 Weeks	No
Secondary	Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)	Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.	78 Weeks	No
Secondary	Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)	Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.	78 Weeks	No
Secondary	Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)	Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.	78 weeks	No
Secondary	Change From Baseline in Dependence Scale Total Score at Week 78	The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.	78 Weeks	No
Secondary	Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78	The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. 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. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.	78 Weeks	No

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