Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

This study has been terminated.
(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00676143
First received: May 2, 2008
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease
Drug: bapineuzumab
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78 [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78 [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]

    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 psychometric 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.



Secondary Outcome Measures:
  • Change From Baseline in Brain Amyloid Burden at Week 71 [ Time Frame: Baseline and 71 weeks ] [ Designated as safety issue: No ]
    Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative 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.

  • Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71 [ Time Frame: Baseline and 71 Weeks ] [ Designated as safety issue: No ]
    Biomarkers CSF phospho-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.

  • Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71 [ Time Frame: Baseline and 71 Weeks ] [ Designated as safety issue: No ]
    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.

  • Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78 [ Time Frame: Week 39 to Week 78 ] [ Designated as safety issue: No ]
    Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.

  • Divergence of Effect on the DAD Total Scores From Week 39 to Week 78 [ Time Frame: Week 39 to Week 78 ] [ Designated as safety issue: No ]
    Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.

  • Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline 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 median time to first median placebo deterioration was presented.

  • Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.

  • Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    The time to first median placebo deterioration 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.

  • Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Dependence Scale Total Score at Week 78 [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining "deterioration" for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.

  • Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score was <7.

  • Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining "deterioration" for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.

  • Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan) [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.

  • Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78 [ Time Frame: Baseline and 78 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 1100
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bapineuzumab 0.5 mg/kg Drug: bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Other Name: AAB-001
Placebo Comparator: Placebo Drug: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

  Eligibility

Ages Eligible for Study:   50 Years to 88 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676143

  Hide Study Locations
Locations
United States, Alabama
Center for Psychiatric Medicine
Birmingham, Alabama, United States, 35294
Participant and Clinical Interactions Resources
Birmingham, Alabama, United States, 35294
UAB Clinical Research Pharmacy-Russell Clinic
Birmingham, Alabama, United States, 35294
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Jeffrey S. Gitt, DO, PC
Phoenix, Arizona, United States, 85032
The Compounding Center
Phoenix, Arizona, United States, 85032
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, Arkansas
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
AC Institute, Incorporated
Carson, California, United States, 90746
Collaborative Neuroscience Network, Inc
Long Beach, California, United States, 90806
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
United States, Colorado
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States, 80304
Associated Neurologists, PC
Boulder, Colorado, United States, 80304
Mile HIgh Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States, 06824
Bendheim Cancer Center
Greenwich, Connecticut, United States, 06830
Center for Healthy Aging
Greenwich, Connecticut, United States, 06830
Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
Hospital Research Unit
New Haven, Connecticut, United States, 06510
Investigational Drug Service
New Haven, Connecticut, United States, 06511
Moshe Hasbani, MD
New Haven, Connecticut, United States, 06511
Yale PET Center
New Haven, Connecticut, United States, 06520
MR Research Center
New Haven, Connecticut, United States, 06520
Norman S. Werdiger, MD
New Haven, Connecticut, United States, 06519
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
JEM Research Institute, LLC
Atlantis, Florida, United States, 33462
Medical Specialist of the Palm Beaches
Atlantis, Florida, United States, 33462
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33418
Neurostudies Inc
Port Charlotte, Florida, United States, 33952
Roskamp Institute
Sarasota, Florida, United States, 34243
University of South Florida
Tampa, Florida, United States, 33613
United States, Georgia
Neurostudies.net
Decatur, Georgia, United States, 30033
Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
Decatur, Georgia, United States, 30033
NeuroStudies.net
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University School of Medicine Department
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Univeristy ADCRP
Boston, Massachusetts, United States, 02118
General Clincial Research Center (Infusion Location)
Boston, Massachusetts, United States, 02118
IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong
Boston, Massachusetts, United States, 02118
Shields MRI
Dartmouth, Massachusetts, United States, 02747
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States, 01201
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, Michigan
University of Michigan Hospital and Health System
Ann Arbor, Michigan, United States, 48105-2945
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
University of Michigan Health System
Ann Arbor, Michigan, United States, 48110
University of Michigan Health System
Ann Arbor,, Michigan, United States, 48109-5872
Michigan State University
East Lansing, Michigan, United States, 48824
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Center for Pharmaceutical Research P.C.
Kansas City, Missouri, United States, 64114
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Pharmcare USA
Edison, New Jersey, United States, 08837
Alzheimer's Research Corp./Merician Institute for Aging
Manchester, New Jersey, United States, 08759
United States, New York
Neurological Care of Central New York
Liverpool, New York, United States, 13088
United States, North Carolina
Carolina Neuropsychological Services, Inc
Raleigh, North Carolina, United States, 27607
Healthsouth Blue Ridge Surgery Center
Raleigh, North Carolina, United States, 27607
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
Wake Radiology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Ohio State University Imaging@Martha Moorehouse
Columbs, Ohio, United States, 43210
The Ohio State University
Columbs, Ohio, United States, 43210
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Summit Research Network(Oregon) Inc.
Portland, Oregon, United States, 97210
Providence Brain Institute
Portland, Oregon, United States, 97225
Providence Cognitive Assessment Clinic
Portland, Oregon, United States, 97225
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Dr. Michael Gabe (Clinic)
Silverton, Oregon, United States, 97381
United States, Pennsylvania
Abington Neurological Assoc
Abington, Pennsylvania, United States, 19001
Abington Neurological Associates
Abington, Pennsylvania, United States, 19001
Abington Memorial Hosptial
Abington, Pennsylvania, United States, 19001
Andorra MRI of Flourtown
Flourtown, Pennsylvania, United States, 19031
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Investigational New Drug Services
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania-Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
UPENN Clinical and Transitional Research Center
Philadelphia, Pennsylvania, United States, 19104
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
Simpson's Pharmacy
Pawtucket, Rhode Island, United States, 02861
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
MUSC
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78231
Integra Clinical Research
San Antonio, Texas, United States, 78229
Inventive Infusions Solutions
San Antonio, Texas, United States, 78258
Integra Clinical Research
San Antonio, Texas, United States, 78231
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Inventive Infusion Solutions
San Antonio, Texas, United States, 78258
Vista Infusions
San Antonio, Texas, United States, 78231
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
The Pharmacy
Bennington, Vermont, United States, 05201
United States, Wisconsin
Waisman Center (PET only)
Madison, Wisconsin, United States, 53705-2280
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Wm S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53792
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53705
Argentina
Instituto Medico Congreso
Buenos Aires, Argentina, 1090
Cemic University Hospital
Buenos Aires, Argentina, 1431
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABD
Instituto Kremer
Cordoba, Argentina, 5004
Australia, New South Wales
Gosford Hospital; Pharmacy Dept
Gosford, New South Wales, Australia, 2250
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Hornsby Kuringai Hospital
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
CDAMS Ballarat Base Hospital
Ballarat, Victoria, Australia, 3353
Heidelberg Repatriation Hospital
West Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Hollywood Hospital; Pharmacy Dept
Nedlands, Western Australia, Australia, 6009
McCusker Alzheimer's Research Foundation, Inc.
Nedlands, Western Australia, Australia, 6009
Austria
Medizinische Universitaet Graz
Graz, Austria, 8036
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria, A-9020
SZ Sued - Kaiser-Franz-Josef-Spital
Wien, Austria, 1220
Donauspital
Wien, Austria, A-1220
Allg. Krankenhaus der Stadt Wien
Wien, Austria, 1090
Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
Az. St. Jan Ruddershove 35
Brugge, Belgium, 8000
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
H.-Hartziekenhuis Roeselare-Menen
Roeselare, Belgium, 8800
Chile
Psicomedica Research Group
Santiago, Chile, 7530193
Especialidades Medicas LyS
Santiago, Chile
Croatia
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Finland
Ita-Suomen Yliopisto
Kuopio, Finland, FIN-70210
University of Turku / CRST
Turku, Finland, 20520
France
CHU Pellegrin
Bordeaux Cedex, France, 33076
Hopital neurologique du Pr A. Vighetto
Bron, France, 69677
Centre d'Imagerie medicale de Basse Normandie
Caen, France, 14000
CHU de Caen
Caen, France, 14033
Hôpitaux Civils de Colmar
Colmar, France, 68024
CHU de Dijon
Dijon, France, 21033
CHRU de Lille
Lille, France, 59037
Hôpital la Timone
Marseille, France, 13385
CHU Hôpital Gui de Chaulliac
Montpellier, France, 34295
CHU Nord - Hôpital Guillaume et René Laënnec
Nantes - Saint Herblain, France, 44093
Hôpital Cimiez C.M.R.R.
Nice, France, 06000
Service d'Imagerie Medicale
Nice, France, 06002
Hôpital Pitié-Salpétrière
Paris, France, 75651
Groupe Hospitalier Broca-La Rochefoucauld
Paris, France, 75013
Hospital Jean Bernard CIC
Poitiers, France, 86000
C.H.U de Reims
Reims, France, 51092
CHU de Rennes
Rennes Cedex, France, 35064
CHU - Hopital Charles Nicolle
Rouen, France, 76031
CHU Toulouse - Site Casselardit
Toulouse, France, 31300
Hôpital Purpan
Toulouse, France, 31059
Germany
Charite-Universitätsmedizin Berlin
Berlin, Germany, 14050
St. Josef-Klinikum
Bochum, Germany, 44791
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Klinikum der Albert-Ludwigs-Universitaet Freiburg
Freiburg, Germany, 79106
Ortenau Klinikum Offenburg
Offenburg, Germany, 77654
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Italy
A.O. Umberto I
Ancona, Italy, 60020
Sezione di Neurologia - Dipartimento di Neuroscienze
Ancona, Italy, 60020
Clinica Neurologica - II Neurologia
Brescia, Italy, 25123
Unita' Operativa Complessa di Neurologia
Catania, Italy, 95126
Dipartimento di Neuroscienze,
Catania, Italy, 95123
CeSI (Centro di Scienze dell'invecchiamento) -
Chieti, Italy, 66013
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milano, Italy, 20133
Ospedale S. Gerardo
Monza, Italy, 20052
Clinica Neurologica
Roma, Italy, 00128
Unita' Operativa C - Riabilitazione Neurologica
Roma, Italy, 00179
Universita degli Studi di Siena
Siena, Italy, 53100
Japan
Nagoya City University Hospital
Nagoya, Aichi,, Japan, 467-8602
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, Japan, 204-8585
Yachiyo Hospital
Aichi, Japan, 446-8510
Nippon Medical School Chiba Hokusoh Hospital
Chiba, Japan, 270-1694
National Hospital Organization Chiba-East Hospital
Chiba, Japan, 260-8712
Kashiwado Hospital
Chiba, Japan, 260-8656
National Hospital Organization Kokura Medical Center
Fukuoka, Japan, 802-8533
Maebashi Red Cross Hospital
Gunma, Japan, 371-0014
Gunma University Hospital
Gunma, Japan, 371-8511
Shinozuka Hospital
Gunma, Japan, 375-0017
National Hospital Organization Hiroshima-nishi Medical Ctr.
Hiroshima, Japan, 739-0696
Kobe University Hospital
Hyogo, Japan, 650-0017
Nishi-Kobe Medical Center
Hyogo, Japan, 651-2273
Kobe City Hospital Org Kobe City Medical Cente West Hp
Hyogo, Japan, 653-0013
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Kagawa University Hospital
Kagawa, Japan, 761-0793
Nippon Medical School Musashi Kosugi Hospital
Kanagawa, Japan, 211-8533
Yokohama City University Medical Center
Kanagawa, Japan, 232-0024
Shonan Atsugi Hospital
Kanagawa, Japan, 243-8551
Rakuwakai Otowa Hospital
Kyoto, Japan, 607-8062
National Hospital Organization Minami-Kyoto Hospital
Kyoto, Japan, 610-0113
National Hospital Organization Maizuru Medical Center
Kyoto, Japan, 625-8502
National Hospital Organization Matsumoto Medical Center
Nagano, Japan, 399-0021
National Hospital Organization Niigata National Hospital
Niigata, Japan, 945-8585
Okayama University Hospital
Okayama, Japan, 700-8558
National Hospital Organization Minami-Okayama Medical Center
Okayama, Japan, 701-0304
Osaka City University Hospital
Osaka, Japan, 545-8586
Osaka University Hospital
Osaka, Japan, 565-0871
Kansai Medical University Takii Hospital
Osaka, Japan, 570-8507
National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
Shizuoka, Japan, 420-8688
Juntendo University Hospital
Tokyo, Japan, 113-8431
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Japan, 136-0075
Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp
Tokyo, Japan, 145-0065
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan, 193-0998
Mexico
OCA Hospital
Monterrey, Nuevo León, Mexico, 64000
Instituto Biomedico de Investigacion A.C
Aguascalientes, Mexico, 20127
Netherlands
Amphia Ziekenhuis
Breda, Noord Brabant, Netherlands, 4818 CK
Tergooi Ziekenhuizen
Hilversum, Noord Holland, Netherlands, 1213 XZ
Kennemer Gasthuis
Haarlem, The Netherlands, Netherlands, 2035 RC
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Erasmus MC
Rotterdam, Netherlands, 3015 CE
New Zealand
The Memory Clinic
Auckland, NZ, New Zealand, 0622
Signet Research
Christchurch, New Zealand, 8014
Poland
NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
Bydgoszcz, Poland, 85-796
Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i
Krakow, Poland, 31-531
NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
Poznan, Poland, 61-289
Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
Warszawa, Poland, 01-211
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
Warszawa, Poland, 02-097
Portugal
Hospital Fernando da Fonseca
Amadora, Portugal, 2720-276
Hospitais Da Universidade De Coimbra
Coimbra, Portugal, 3000-075
Hospital Santa Maria
Lisboa, Portugal, 1649-028
Serbia
Klinicki centar Srbije
Belgrade, Serbia, 11000
Clinical Centre Kragujevac, Clinic of Psichiatry
Kragujevac, Serbia, 34000
Klinicki Centar Vojvodina
Novi Sad, Serbia, 21000
Diagnostic Imaging Center
Sremska Kamenica, Serbia, 21204
Institute for Cardiovascular Diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Slovakia
Psychiatricka ambulancia
Bratislava, Slovakia, 820 07
Univerzitna nemocnica Bratislava
Bratislava, Slovakia, 825 56
Psychiatricka nemocnica Michalovce, n.o.
Michalovce, Slovakia, 071 01
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, Slovakia, 979 12
South Africa
Boithuso Caregivers
Johannesburg, Gauteng, South Africa, 1709
The Osteoporosis and Memory Centre
Johannesburg, Gauteng, South Africa, 2196
Denmar Clinic
Pretoria, Gauteng, South Africa, 0081
St Augustine's Medical Centre 2
Durban, Kwa Zulu Natal, South Africa, 4001
Flexivest Fourteen Research Center
Bellville, Western Cape, South Africa, 7530
Panorama Psychiatry and Memory Clinic
Panorama, Western Cape, South Africa, 7500
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Virgen del Puerto
Plasencia, Caceres, Spain, 10600
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
CLONUS
Palma de Mallorca, Islas Baleares, Spain, 07014
Hospital de Donostia
San Sebastian, Pais Vasco, Spain, 20014
Hospital de Cruces
Baracaldo, Vizcalla, Spain, 48903
Hospital del Mar
Barcelona, Spain, 08003
Fundacio ACE Institut Catala de Neurociences Aplicades
Barcelona, Spain, 08014
Centro Internacional de Medicina Avanzda (CIMA)
Barcelona, Spain, 08034
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Divino Valles
Burgos, Spain, 09006
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Sweden
Malmo University Hospital
Malmo, Sweden, 21 224
Uppsala Imanet AB
Uppsala, Sweden, 751 09
Akademiska Sjukhuset
Uppsala, Sweden, 75185
ORKI, enheten for radiologi
Uppsala, Sweden, 75185
Switzerland
Memory Clinic Neuro-Psychologie Zentrum
Basel, BS, Switzerland, CH-4031
Hopitaux Universitaires de Geneve
Les Acacias, GE, Switzerland, 1227
CHUV Lausanne
Lausanne, VD, Switzerland, 1005
Hopitaux Universitaires de Geneve
Thonex-Geneva, Switzerland, CH-1226
United Kingdom
MAC UK Neuroscience Ltd
Blackpool, Lancashire, United Kingdom, FY2 0JH
MAC UK Neuroscience, Research Assessment Centre
Trafford Park, Manchester, United Kingdom, M32 0UT
Pollard Park Health Centre
Bradford, United Kingdom, BD3 0DQ
Clinical Investigation and Research Unit (CIRU)
Brighton, United Kingdom, BN2 5BE
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 0XA
Kings College Hospital
London, United Kingdom, SE5 9RS
Dept. of Neurosciences Charing Cross Hospital
London, United Kingdom, W6 8RF
Newcastle General Hospital
Newcastle upon Tyne, United Kingdom, NE4 5PL
Northampton General Hospital
Northampton, United Kingdom, NN1 5BD
Llandough Hospital
Penarth, United Kingdom, CF64 2XX
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Grenoside Grange Hospital
Sheffield, United Kingdom, S35 8QS
Victoria Hospital
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676143     History of Changes
Obsolete Identifiers: NCT00909675
Other Study ID Numbers: 3133K1-3001  B2521002  2007-005995-14 
Study First Received: May 2, 2008
Results First Received: October 14, 2013
Last Updated: May 3, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
antibody
immunotherapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2016