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: December 20, 2012
Last verified: December 2012
  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 In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Carriers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale Total Score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Disability Assessment for Dementia Total Score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain Amyloid Burden [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • CSF Phospho-Tau level [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • MRI Brain Boundary Shift Integral [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
  • Divergence of effect [ Time Frame: 39 Weeks ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Dependence Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Proportion of responders [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating Sum of Boxes [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1099
Study Start Date: May 2008
Study Completion Date: October 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
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

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
United States, Arizona
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Goodyear, Arizona, United States, 85395
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Phoenix, Arizona, United States, 85050
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Phoenix, Arizona, United States, 85006
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Phoenix, Arizona, United States, 85032
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Carson, California, United States, 90746
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Long Beach, California, United States, 90806
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San Francisco, California, United States, 94109
United States, Colorado
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Boulder, Colorado, United States, 80304
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Denver, Colorado, United States, 80218
United States, Connecticut
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Fairfield, Connecticut, United States, 06824
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Greenwich, Connecticut, United States, 06830
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New Haven, Connecticut, United States, 06520
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New Haven, Connecticut, United States, 06511
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New Haven, Connecticut, United States, 06510
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New Haven, Connecticut, United States, 06519
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Norwalk, Connecticut, United States, 06851
United States, Florida
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Atlantis, Florida, United States, 33462
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Delray Beach, Florida, United States, 33445
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Orlando, Florida, United States, 32806
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Palm Beach Gardens, Florida, United States, 33418
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Port Charlotte, Florida, United States, 33952
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Sarasota, Florida, United States, 34243
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Tampa, Florida, United States, 33613
United States, Georgia
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Decatur, Georgia, United States, 30033
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Lawrenceville, Georgia, United States, 30045
United States, Illinois
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Elk Grove Village, Illinois, United States, 60007
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Springfield, Illinois, United States, 62781
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Springfield, Illinois, United States, 62702
United States, Kansas
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Kansas, Kansas, United States, 66160
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Kansas City, Kansas, United States, 66160
United States, Louisiana
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Lake Charles, Louisiana, United States, 70629
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02115
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Boston, Massachusetts, United States, 02118
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Dartmouth, Massachusetts, United States, 02747
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Pittsfield, Massachusetts, United States, 01201
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Springfield, Massachusetts, United States, 01104
United States, Michigan
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Ann Arbor, Michigan, United States, 48105-2945
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Ann Arbor, Michigan, United States, 48110
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Ann Arbor, Michigan, United States, 48109
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Ann Arbor,, Michigan, United States, 48109-5872
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East Lansing, Michigan, United States, 48824
United States, Mississippi
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Hattiesburg, Mississippi, United States, 39401
United States, Missouri
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Kansas City, Missouri, United States, 64114
United States, New Jersey
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Eatontown, New Jersey, United States, 07724
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Edison, New Jersey, United States, 08837
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Manchester, New Jersey, United States, 08759
United States, New York
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Liverpool, New York, United States, 13088
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
United States, Ohio
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Columbs, Ohio, United States, 43210
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Columbus, Ohio, United States, 43210
United States, Oregon
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Portland, Oregon, United States, 97225
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Portland, Oregon, United States, 97210
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Silverton, Oregon, United States, 97381
United States, Pennsylvania
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Abington, Pennsylvania, United States, 19001
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Jenkintown, Pennsylvania, United States, 19046
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
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Pawtucket, Rhode Island, United States, 02861
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Providence, Rhode Island, United States, 02906
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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North Charleston, South Carolina, United States, 29406
United States, Texas
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Dallas, Texas, United States, 75214
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78231
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San Antonio, Texas, United States, 78229
United States, Vermont
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Bennington, Vermont, United States, 05201
United States, Wisconsin
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Madison, Wisconsin, United States, 53705-2280
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Madison, Wisconsin, United States, 53792
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Madison, Wisconsin, United States, 53705
Argentina
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Buenos Aires, Argentina, C1199ABD
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Buenos Aires, Argentina, 1431
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Buenos Aires, Argentina, 1090
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Cordoba, Argentina, 5004
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
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Hornsby, New South Wales, Australia, 2077
Australia, South Australia
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Woodville South, South Australia, Australia, 5011
Australia, Victoria
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Ballarat, Victoria, Australia, 3353
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West Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Australia
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Adelaide, Australia, 5000
Austria
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Graz, Austria, 8036
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Klagenfurt, Austria, A-9020
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Wien, Austria, 1090
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Wien, Austria, 1220
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Wien, Austria, A-1220
Belgium
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Antwerpen, Belgium, 2020
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Brugge, Belgium, 8000
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Brussels, Belgium, 1200
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Roeselare, Belgium, 8800
Chile
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Santiago, Chile
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Santiago, Chile, 7530193
Croatia
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Zagreb, Croatia, 10000
Finland
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Kuopio, Finland, FIN-70210
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Turku, Finland, 20520
France
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Bordeaux Cedex, France, 33076
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Bron, France, 69677
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Caen, France, 14000
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Caen, France, 14033
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Colmar, France, 68024
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Dijon, France, 21033
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Lille, France, 59037
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Marseille, France, 13385
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Montpellier, France, 34295
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Nantes - Saint Herblain, France, 44093
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Nice, France, 06000
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Nice, France, 06002
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Paris, France, 75651
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Paris, France, 75013
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Poitiers, France, 86000
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Reims, France, 51092
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Rennes Cedex, France, 35064
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Rouen, France, 76031
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Toulouse, France, 31059
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Toulouse, France, 31300
Germany
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Berlin, Germany, 14050
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Bochum, Germany, 44791
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Dresden, Germany, 01307
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Freiburg, Germany, 79106
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Offenburg, Germany, 77654
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Ulm, Germany, 89081
Italy
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Ancona, Italy, 60020
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Brescia, Italy, 25123
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Catania, Italy, 95123
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Catania, Italy, 95126
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Chieti, Italy, 66013
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Milano, Italy, 20133
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Monza, Italy, 20052
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Roma, Italy, 00128
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Roma, Italy, 00179
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Siena, Italy, 53100
Japan
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Nagoya, Aichi,, Japan
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Kiyose, Tokyo, Japan
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Aichi, Japan
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Chiba, Japan
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Fukuoka, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hyogo, Japan
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Iwate, Japan
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Kagawa, Japan
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Kanagawa, Japan
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Kyoto, Japan
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Nagano, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Shizuoka, Japan
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Tokyo, Japan
Mexico
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Monterrey, Nuevo León, Mexico, 64000
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Aguascalientes, Mexico, 20127
Netherlands
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Breda, Noord Brabant, Netherlands, 4818 CK
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Hilversum, Noord Holland, Netherlands, 1213 XZ
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's-Hertogenbosch, Netherlands, 5223 GZ
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Alkmaar, Netherlands, 1815 JD
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Amsterdam, Netherlands, 1081 HV
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Eindhoven, Netherlands, 5623 EJ
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Leeuwarden, Netherlands, 8934 AD
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Rotterdam, Netherlands, 3015 CE
New Zealand
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Auckland, NZ, New Zealand, 0622
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Christchurch, New Zealand, 8014
Poland
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Bydgoszcz, Poland, 85-796
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Krakow, Poland, 31-531
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Poznan, Poland, 61-289
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Warszawa, Poland, 02-097
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Warszawa, Poland, 01-211
Portugal
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Amadora, Portugal, 2720-276
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Coimbra, Portugal, 3000-075
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Lisboa, Portugal, 1649-028
Serbia
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Novi Sad, Serbia, 21000
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Sremska Kamenica, Serbia, 21204
Slovakia
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Bratislava, Slovakia, 825 56
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Bratislava, Slovakia, 820 07
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Michalovce, Slovakia, 071 01
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Rimavska Sobota, Slovakia, 979 12
South Africa
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Johannesburg, Gauteng, South Africa, 1709
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Johannesburg, Gauteng, South Africa, 2196
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Pretoria, Gauteng, South Africa, 0081
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Durban, Kwa Zulu Natal, South Africa, 4001
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Bellville, Western Cape, South Africa, 7530
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Panorama, Western Cape, South Africa, 7500
Spain
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Elche, Alicante, Spain, 03203
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Terrassa, Barcelona, Spain, 08221
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Plasencia, Caceres, Spain, 10600
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Palma de Mallorca, Islas Baleares, Spain, 07010
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Palma de Mallorca, Islas Baleares, Spain, 07014
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San Sebastian, Pais Vasco, Spain, 20014
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Baracaldo, Vizcalla, Spain, 48903
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Barcelona, Spain, 08041
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Barcelona, Spain, 08003
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Barcelona, Spain, 08014
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Barcelona, Spain, 08034
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Burgos, Spain, 09006
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Madrid, Spain, 28006
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Madrid, Spain, 28041
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Madrid, Spain, 28040
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Madrid, Spain, 28046
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Madrid, Spain, 28034
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Murcia, Spain, 30120
Sweden
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Malmo, Sweden, 21 224
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Uppsala, Sweden, 75185
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Uppsala, Sweden, 751 09
Switzerland
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Basel, BS, Switzerland, CH-4031
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Les Acacias, GE, Switzerland, 1227
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Lausanne, VD, Switzerland, 1005
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Thonex-Geneva, Switzerland, CH-1226
United Kingdom
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Blackpool, Lancashire, United Kingdom, FY2 0JH
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Trafford Park, Manchester, United Kingdom, M32 0UT
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Bradford, United Kingdom, BD3 0DQ
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Brighton, United Kingdom, BN2 5BE
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Glasgow, United Kingdom, G20 0XA
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London, United Kingdom, SE5 9RS
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London, United Kingdom, W6 8RF
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Newcastle upon Tyne, United Kingdom, NE4 5PL
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Northampton, United Kingdom, NN1 5BD
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Penarth, United Kingdom, CF64 2XX
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Sheffield, United Kingdom, S35 8QS
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Sheffield, United Kingdom, S10 2JF
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Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676143     History of Changes
Obsolete Identifiers: NCT00909675
Other Study ID Numbers: 3133K1-3001, B2521002
Study First Received: May 2, 2008
Last Updated: December 20, 2012
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014