Study Evaluating The Efficacy And Safety 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:
NCT00667810
First received: April 24, 2008
Last updated: December 4, 2015
Last verified: December 2015
  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 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78 [ Time Frame: 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.

  • The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78 [ Time Frame: 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 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.


Secondary Outcome Measures:
  • The Change From Baseline in Brain Amyloid Burden at Week 71. [ Time Frame: 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 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.

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

  • The Change From Baseline in Brain Volume at Week 71 [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
    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.

  • Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78 [ Time Frame: 39 Weeks ] [ Designated as safety issue: No ]
    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.

  • Divergence of Effect on the DAD Total Scores From Week 39 to Week 78 [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan) [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
    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.

  • Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to Median Placebo Deterioration on DAD Total Score [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
    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.

  • Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan) [ Time Frame: 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.

  • Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan) [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.

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

  • Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan) [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.

  • Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan) [ Time Frame: 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 Dependence Scale Total Score at Week 78 [ Time Frame: 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.

  • Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78 [ Time Frame: 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: 901
Study Start Date: June 2008
Study Completion Date: August 2013
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
Experimental: Bapineuzumab 1.0 mg/kg Drug: bapineuzumab
Bapineuzumab 1.0 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 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
  • Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
  • Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
  • Women of childbearing potential
  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: NCT00667810

  Hide Study Locations
Locations
United States, Alabama
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 (IP Mixing Only)
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
ATP Clinical Research, Incorporated
Costa Mesa, California, United States, 92626
Pharmacology Research Institute
Encino, California, United States, 91316
Margolin Brain Institute
Fresno, California, United States, 93720
Infusion Care Pharmacey
Laguna Hills, California, United States, 92653
Senior Clinical Trials, Incorporated
Laguna Hills, California, United States, 92653
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Coordinated Clinical Research
San Diego, California, United States, 92103
LabCorp
San Diego, California, United States, 92103
Sharp and Children's MRI Center, LLC
San Diego, California, United States, 92123
Sharp Infusion Therapy Center
San Diego, California, United States, 92123
Sharp Memorial Hospital
San Diego, California, United States, 92123
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
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
The Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Associated Neurologists, PC
Danbury, Connecticut, United States, 06810
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
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06511
Norman S. Werdiger, MD
New Haven, Connecticut, United States, 06519
Institutional Review Board / Ethics Committee
New Haven, Connecticut, United States, 06520
Yale PET Center
New Haven, Connecticut, United States, 06520
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
JEM Research Institute LLC
Atlantis, Florida, United States, 33462
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States, 33462
Bradenton Research Center, Incorporated
Bradenton, Florida, United States, 34205
North Broward Medical Center
Deerfield Beach, Florida, United States, 33064
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, United States, 33308
MD Clinical
Hallandale Beach, Florida, United States, 33009
Renstar Medical Research
Ocala, Florida, United States, 34471
Advanced Imaging
Ocala, Florida, United States, 34481
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33410
Neurostudies Inc
Port Charlotte, Florida, United States, 33952
Roskamp Institute
Sarasota, Florida, United States, 34243
South Bay Internal Medicine
Sun City, Florida, United States, 33573
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
NeuroTrials Research, Incorporated
Atlanta, Georgia, United States, 30342
Columbus Diagnostic Center (MRI)
Columbus, Georgia, United States, 31901
Medical Research and Health Education Foundation, Incorporated
Columbus, Georgia, United States, 31909
Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
Decatur, Georgia, United States, 30033
NeuroStudies.net
Decatur, Georgia, United States, 30033
Neurostudies.net
Lawerenceville, Georgia, United States, 30045
Neurostudies.net
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States, 60007
Methodist Center for Senior Health
Peoria, Illinois, United States, 61602
Methodist Medical Center Research Department
Peoria, Illinois, United States, 61602
Methodist Diagnostic Center
Peoria, Illinois, United States, 61606
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514
Psychology Associates
Mishawaka, Indiana, United States, 46545
United States, Kansas
KU - Wichita
Wichita, Kansas, United States, 67207
Drug Shipment/ Storage
Wichitia, Kansas, United States, 67205
United States, Kentucky
Four Rivers Clinical Research, Incorporated
Paducah, Kentucky, United States, 42003
Radio Pharmacy
Paducah, Kentucky, United States, 42003
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
Louisiana Research Associates Inc
New Orleans, Louisiana, United States, 70114
James Gary Booker, MD, APMC
Shreveport, Louisiana, United States, 71104
United States, Maryland
Foers Medical Arts Pharmacy
Bethesda, Maryland, United States, 20814
CBH Health, LLC
Rockville, Maryland, United States, 20850
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 021147
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Bringham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University
Boston, Massachusetts, United States, 02118
General Clinical Research Center
Boston, Massachusetts, United States, 02118
IDS Pharmacy
Boston, Massachusetts, United States, 02118
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, United States, 01830
Neurocare, Incorporated
Newton, Massachusetts, United States, 02459
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5872
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
University of Michigan Health System
Ann Arbor, Michigan, United States, 48110
Michigan State University
East Lansing, Michigan, United States, 48824
Michigan State University
Lansing, Michigan, United States, 48910
United States, Mississippi
Marty's Pharmacy
Flowood, Mississippi, United States, 39232
Precise Research Centers
Flowood, Mississippi, United States, 39232
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Montana
Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
Spectrum Home Solutions
Great Falls, Montana, United States, 59405
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Alzheimer's Research Corporation
Manchester, New Jersey, United States, 08759
Memory Enhancement Center of New Jersey, Inc.
Toms River, New Jersey, United States, 08755
United States, New York
Northeast Radiology
Brewster, New York, United States, 10509
Neurological Care of Central New York
Liverpool, New York, United States, 13088
AD-CARE, University of Rochester Medical Center
Rochester, New York, United States, 14620
University of Rochester/Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, North Carolina
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States, 28803
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28211
Clinical Trials of America, Incorporated
Hickory, North Carolina, United States, 28601
The Compounding Pharmacy
Hickory, North Carolina, United States, 28602
Carolina Neuropsychological Services, Inc.
Raleigh, North Carolina, United States, 27607
Healthsouth Blue Ridge Surgery Center
Raleigh, North Carolina, United States, 27607
Raleigh Neurology Associates, PA
Raleigh, North Carolina, United States, 27607
Wake Radiology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Ohio State University Imaging at Martha Morehouse
Columbus, Ohio, United States, 43210
The Ohio State University Hospitals Clinic
Columbus, Ohio, United States, 43210
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
The Ohio State University
Columbus, Ohio, United States, 43210
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
Professional Corporation of Psychiatry
Oklahoma City, Oklahoma, United States, 73112
Red River Medical Recearch Center, LLC
Oklahoma City, Oklahoma, United States, 73112
Flourish Integrative Pharmacy
Oklahoma City, Oklahoma, United States, 73134
United States, Oregon
Providence Brain Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Abington Neurological Associates
Abington, Pennsylvania, United States, 19001
Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania (PET)
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Investigational New Drug Services, IDS Pharmacy
Philadelphia, Pennsylvania, United States, 19104
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
UPENN Clinical and Translational Research Center (CTRC)
Philadelphia, Pennsylvania, United States, 19104
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
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 Investigational Drug Service
Charleston, South Carolina, United States, 29425
Radiant Research, Incorporated
Greer, South Carolina, United States, 29651
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Neurology Clinic, PC
Cordova, Tennessee, United States, 38018
United States, Texas
Austin Infusion Centers
Austin, Texas, United States, 78756
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78231
Vista Infusions
San Antonio, Texas, United States, 78231
Inventive Infusion Solutions
San Antonio, Texas, United States, 78258
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Vermont
Southwestern Vermont Healthcare
Bennington, Vermont, United States, 05201
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
University of Virginia Neurology
Charlottesville, Virginia, United States, 22903
University of Virginia General Clinical Research Center
Charlottesville, Virginia, United States, 22908
University of Viriginia Investigational Pharmacy
Charlottesville, Virginia, United States, 22908
United States, Washington
Pacific Medical Centers
Bothell, Washington, United States, 98021
Pacific Medical Centers
Seattle, Washington, United States, 98144
Argentina
Cemic University Hospital
Buenos Aires, Argentina, 1431
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Hornsby Kuringai Hospital
Hornsby, New South Wales, Australia, 02077
Australia, South Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
CDAMS Ballarat Base Hospital
Ballarat, Victoria, Australia, 3353
Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
West Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
McCusker Alzheimer's Research Foundation Inc.
Nedlands, Western Australia, Australia, 6009
Australia
Royal Adelaide Hospital
Adelaide SA, Australia, 5000
Belgium
ZNA Middelheim / Neurologie
Antwerpen, Belgium, 2020
Az. St. Jan Ruddershove 35
Brugge, Belgium, 8000
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
University Hospital Gathuisberg
Leuven, Belgium, 3000
H.-Hartziekenhuis Roeselare-Menen
Roeselare, Belgium, 8800
Canada, Ontario
Centre for Memory and Aging
North York, Ontario, Canada, M6M 3Z5
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre de Recherche ADAPRA Inc.
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Recherche Clinique de Neurologie
Montreal, Quebec, Canada, H1T 2M4
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
ALPHA Recherche Clinique
Quebec, Canada, G3K 2P8
Chile
Psicomedica Research Group
Santiago, Chile, 7530193
Especialidades Medicas L&S
Santiago, Chile
Croatia
Sestre milosrdnice Zagreb
Zagreb, Croatia, 10000
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Finland
Ita-Suomen Yliopisto
Kuopio, Finland, FIN-70210
Turku University Hospital
Turku, Finland, 20520
France
CHRU Hôtel Dieu
Rennes, Cedex, France, 35064
CHU Hopital Nord
Amiens, France, 80054
Hôpital Neurologique
Bron, France, 69677
CHU de Caen
Caen, France, 14033
Hôpitaux Civils de Colmar
Colmar, France, 68024
CHU de Dijon
Dijon, France, 21000
Hôpital Roger Salengro
Lille, France, 59037
Hopital Sainte Marguerite
Marseille, France, 13009
Hôpital la Timone
Marseille, France, 13885
CHU Hôpital Gui de Chaulliac
Montpellier, France, 34295
CHU Nord - Hôpital Guillaume et René Laënnec
Nantes - Saint Herblain, France, 44093
Hôpital Cimiez
Nice, France, 06000
Groupe Hospitalier Pitie-Salpetriere
Paris Cedex 13, France, 75651
Groupe Hospitalier Broca-La Rochefoucauld
Paris, France, 75013
CHU La Milétrie
Poitiers, France, 86021
C.H.U de Reims
Reims, France, 51000
CHU - Hopital Charles Nicolle
Rouen, France, 76031
Hôpital Purpan
Toulouse, France, 31059
CHU Purpan - Hôpital Casselardit
Toulouse, France, 31300
Germany
Klinik fur Psychiatrie und Psychotherapie
Berlin, Germany, 14050
St. Josef-Klinikum
Bochum, Germany, 44791
Ortenau Klinikum
Offenburg, Germany, 77654
Universitaet Regensburg
Regensburg, Germany, 93053
Italy
Universita Politecnica delle Marche
Ancona, Italy, 60020
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Unita' Operativa Complessa di Neurologia
Catania, Italy, 95126
CeSI (Centro di Scienze dell'invecchiamento) -
Chieti, Italy, 66013
Universita degli Studi di Firenze
Firenze, Italy, 50131
Ospedale S. Raffaele
Milano, Italy, 20127
Ospedale S. Raffaele
Milano, Italy, 20132
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milano, Italy, 20133
Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
Monza, Italy, 20052
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
Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
Ota-ku, Tokyo, Japan, 145-0065
Yachiyo Hospital
Aichi, Japan, 446-8510
Kashiwado Hospital
Chiba, Japan, 260-8656
National Hospital Organization Chiba-East Hospital
Chiba, Japan, 260-8712
Nippon Medical School Chiba Hokusoh Hospital
Chiba, Japan, 270-1694
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 Musashikosugi 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 Medical University Hospital
Tokyo, Japan, 160-0023
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan, 193-0944
National Hospital Organization Tokyo National Hospital
Tokyo, Japan, 204-8585
Korea, Republic of
Seoul National University Bundang Hospital, Department of Psychiatry
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
KonKuk University Hospital, Department of NeuroPsychiatry
Seoul, Korea, Republic of, 143-729
Mexico
OCA Hospital
Monterrey, Nuevo León, Mexico, 64000
Instituto Biomedico de Investigacion A.C
Aguascalientes, Mexico, 20127
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Kennemer Gasthuis
Haarlem, Netherlands, 2035 RC
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Jeroen Bosch Ziekenhuis
s. Hertogenbosch, Netherlands, 5223 GZ
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
NZOZ "SYNAPSA", ul. Niska 5/1
Kielce, Poland, 25-317
Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
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, 2700-276
Hospitais Da Universidade De Coimbra
Coimbra, Portugal, 3000-075
Hospital Santa Maria
Lisboa, Portugal, 1649-028
Russian Federation
Interregional clinicodiagnostic center
Kazan, Russian Federation, 420101
Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
Nizhny Novgorod, Russian Federation, 603126
Saint-Petersburg State institution of healthcare, City geriatric medico-social center
Saint-Petersburg, Russian Federation, 190103
Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
Saint-Petersburg, Russian Federation, 192019
Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
Saint-Petersburg, Russian Federation, 192019
Chair of nervous system diseases
Saint-Petersburg, Russian Federation, 194044
Serbia
Klinicki centar Vojvodine
Novi Sad, Vojvodina, Serbia, 21000
Klinicki centar Srbije
Belgrade, Serbia, 11000
Klinicki centar Srbije
Beograd, Serbia, 11000
Clinical Centre Kragujevac
Kragujevac, Serbia, 34000
Slovakia
1. Neurologicka klinika
Bratislava, Slovakia, 813 69
Psychiatricka ambulancia
Bratislava, Slovakia, 820 07
Univerzitna nemocnica Bratislava
Bratislava, Slovakia, 825 56
Univerzitna nemocnica Bratislava
Bratislava, Slovakia, 826 06
Neurologicka klinika
Martin, Slovakia, 036 59
Psychiatricka nemocnica Michalovce, n.o.
Michalovce, Slovakia, 071 01
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, Slovakia, 979 12
Neurologicke oddelenie FNsP Zilina
Zilina, Slovakia, 012 07
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
Panorama Psychiatry and Memory Clinic
Panorama, Western Cape, South Africa, 7505
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Mutua de Terrasa
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 Cruces
Baracaldo, Spain, 48903
Hospital del Mar
Barcelona, Spain, 08003
Fundació ACE Institut Catala de Neurociences Aplicades
Barcelona, Spain, 08029
Clínica CIMA
Barcelona, Spain, 08034
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Divino Valles
Burgos, Spain, 09006
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Sweden
Skanes Universitetssjukhus, Neuropsykiatriska
Malmo, Sweden, 21 224
PET center
Uppsala, Sweden, 751 09
The clinic: Minnes- och geriatrikmottagningen
Uppsala, Sweden, 751 85
MRI Dept: ORKI
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, Ltd.
Bradford, West Yorkshire, 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 NHS Trust
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
Kingshill Research Centre
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: NCT00667810     History of Changes
Obsolete Identifiers: NCT00909623
Other Study ID Numbers: 3133K1-3000  B2521001  2007-005994-79 
Study First Received: April 24, 2008
Results First Received: October 22, 2013
Last Updated: December 4, 2015
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 August 25, 2016