A Long-Term Safety And Tolerability Extension Study 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:
NCT00998764
First received: October 16, 2009
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.


Condition Intervention Phase
Alzheimer Disease
Drug: Bapineuzumab 0.5 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Extension, Multicenter, Long-term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Carriers And Participated In Study 3133K1-3001.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of treatment emergent adverse events, clinically important changes in vital signs, weight, ECG, laboratory determinations, brain magnetic resonance imaging (MRI), physical and neurological examinations and infusion site assessments [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale; Disability Assessment for Dementia, Neuropsychiatric Inventory [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 493
Study Start Date: December 2009
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 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Name: AAB-001

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
  • Mini-Mental Status Examination (MMSE) >=10 at screening
  • Caregiver able to attend all clinic visits with subject

Exclusion Criteria:

  • Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
  • Any significant brain MRI abnormality.
  • Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
  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: NCT00998764

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35249
United States, Arizona
Pfizer Investigational Site
Goodyear, Arizona, United States, 85395
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
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Phoenix, Arizona, United States, 85032
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94109
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States, 80304
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Denver, Colorado, United States, 80218
United States, Connecticut
Pfizer Investigational Site
Fairfield, Connecticut, United States, 06824
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Greenwich, Connecticut, United States, 06830
Pfizer Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
Pfizer Investigational Site
Atlantis, Florida, United States, 33462
Pfizer Investigational Site
Delray Beach, Florida, United States, 33445
Pfizer Investigational Site
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, 34234
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Tampa, Florida, United States, 33613
United States, Georgia
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Pfizer Investigational Site
Elk Grove Village, Illinois, United States, 60007
Pfizer Investigational Site
Springfield, Illinois, United States, 62702
United States, Louisiana
Pfizer Investigational Site
Lake Charles, Louisiana, United States, 70629
United States, Massachusetts
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01104
United States, Michigan
Pfizer Investigational Site
East Lansing, Michigan, United States, 48848
Pfizer Investigational Site
East Lansing, Michigan, United States, 48824
United States, Mississippi
Pfizer Investigational Site
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Charleston, South Carolina, United States, 29245
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Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
North Charleston, South Carolina, United States, 29406
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75214
Pfizer Investigational Site
San Antonio, Texas, United States, 78231
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78229
Argentina
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Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
Pfizer Investigational Site
Hornsby, New South Wales, Australia, 2207
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Pfizer Investigational Site
Woodville South, South Australia, Australia, 5011
Australia, Victoria
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Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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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Leuven, Belgium, 3000
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Roeselare, Belgium, 8800
Chile
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Santiago, Chile, 7530193
Finland
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Kuopio, Finland, FIN-70210
Pfizer Investigational Site
Turku, Finland, FIN-20520
France
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Bordeaux, France, 33076
Pfizer Investigational Site
Bron, France, 69677
Pfizer Investigational Site
Caen, France, 14033
Pfizer Investigational Site
Colmar, France, 68024
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Marseille, France, 13885
Pfizer Investigational Site
Marseille cedex 5, France, 13385
Pfizer Investigational Site
Montpellier, France, 34295
Pfizer Investigational Site
Nantes - Saint Herblain, France, 44093
Pfizer Investigational Site
Nice, France, 06000
Pfizer Investigational Site
Paris, France, 75013
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Poitiers, France, 86021
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Reims, France, 51000
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Rennes, France, 35064
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Rennes Cedex 9, France, 35033
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Rouen Cedex, France, 76031
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Toulouse, France, 31300
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Toulouse, France, 31059
Italy
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Ancona, Italy, 60020
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Catania, Italy, 95123
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Milano, Italy, 20133
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Roma, Italy, 00179
Japan
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Nagoya, Aichi,, Japan
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Aichi, Japan
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Chiba, Japan
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Chiba-shi, 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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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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Tokyo, Japan
Netherlands
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's-HERTOGENBOSCH, Netherlands, 5223 GZ
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Amsterdam, Netherlands, 1081 HV
New Zealand
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Christchurch, NZ, New Zealand, 8014
Pfizer Investigational Site
Auckland, New Zealand, 0622
Pfizer Investigational Site
Christchurch, New Zealand, 8011
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-796
Pfizer Investigational Site
Poznan, Poland, 60-693
Pfizer Investigational Site
Poznan, Poland, 61-289
Pfizer Investigational Site
Warszawa, Poland, 02-097
Pfizer Investigational Site
Warszawa, Poland, 01-211
Portugal
Pfizer Investigational Site
Amadora, Lisboa, Portugal, 2720-276
Pfizer Investigational Site
Coimbra, Portugal, 3000-075
Pfizer Investigational Site
Lisboa, Portugal, 1649-028
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 825 56
Pfizer Investigational Site
Rimavska Sobota, Slovakia, 979 12
South Africa
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Johannesburg, Gauteng, South Africa, 2196
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 1709
Pfizer Investigational Site
Durban, Kwa Zulu Natal, South Africa, 4001
Pfizer Investigational Site
Bellville, Western Cape, South Africa, 7530
Spain
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Elche, Alicante, Spain, 03203
Pfizer Investigational Site
Terrasa, Barcelona, Spain, 08221
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Plasencia, Caceres, Spain, 10600
Pfizer Investigational Site
Palma de Mallorca, Islas Baleares, Spain, 07010
Pfizer Investigational Site
Palma de Mallorca, Islas Baleares, Spain, 07014
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Barcelona, Spain, 08034
Pfizer Investigational Site
Barcelona, Spain, 08014
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Barcelona, Spain, 08003
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Burgos, Spain, 09006
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Madrid, Spain, 28006
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Madrid, Spain, 28046
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Madrid, Spain, 28040
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Murcia, Spain, 30120
Sweden
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Malmo, Sweden, 21 224
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Uppsala, Sweden, 75185
Switzerland
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Basel, BS, Switzerland, CH-4031
United Kingdom
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Grenoside, Sheffield, United Kingdom, S35 8QS
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Cardiff, Wales, United Kingdom, CF4 4XW
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Bradford, United Kingdom, BDQ0DQ
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Brighton, United Kingdom, BN2 5BE
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Glasgow, United Kingdom, G20 OXA
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London, United Kingdom, WIT 4EU
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London, United Kingdom, W6 8RF
Pfizer Investigational Site
Newcastle upon Tyne, United Kingdom, NE4 5PL
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Northampton, United Kingdom, NN1 5BD
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Sheffield, United Kingdom, S10 2JF
Pfizer Investigational Site
Swindon, United Kingdom, SN3 6BW
Pfizer Investigational Site
Wakefield, United Kingdom, WF1 4TT
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: NCT00998764     History of Changes
Other Study ID Numbers: 3133K1-3003, B2521004
Study First Received: October 16, 2009
Last Updated: September 11, 2013
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 July 20, 2014