A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
NCT ID: NCT00996918
Last Updated: 2014-01-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
198 participants
INTERVENTIONAL
2009-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bapineuzumab 0.5 mg/kg
bapineuzumab
Bapineuzumab 0.5 mg/kg
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Bapineuzumab 1.0 m/kg
bapineuzumab
Bapineuzumab 1.0 m/kg
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Interventions
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Bapineuzumab 0.5 mg/kg
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Bapineuzumab 1.0 m/kg
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mini-Mental Status Examination (MMSE) \>=10 at screening
* Caregiver able to attend all clinic visits with subject
Exclusion Criteria
* Any significant brain MRI abnormality.
* Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
51 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Hornsby, New South Wales, Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Woodville South, South Australia, Australia
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Heidelberg Heights, Victoria, Australia
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Nedlands, Western Australia, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Santiago, Chile, Chile
Pfizer Investigational Site
Santiago, Chile, Chile
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Kuopio, , Finland
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Turku, , Finland
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Dijon, France, France
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Lille, France, France
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Marseille, France, France
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Paris, France, France
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Caen, , France
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Marseille, , France
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Montpellier, , France
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Nantes - Saint Herblain, , France
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Nice, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Toulouse, , France
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Milan, , Italy
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Roma, , Italy
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hyōgo, , 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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Okayama, , Japan
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Osaka, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
Pfizer Investigational Site
's-Hertogenbosch, , Netherlands
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Leeuwarden, , Netherlands
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North Shore, NZ, New Zealand
Pfizer Investigational Site
Poznan, Poland, Poland
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Bydgoszcz, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Amadora, Amadora, Portugal
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Coimbra, Coimbra District, Portugal
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Lisbon, Lisbon District, Portugal
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Bratislava, , Slovakia
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Rimavská Sobota, , Slovakia
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
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Elche, Alicante, Spain
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Burgos, Burgos, Spain
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Plasencia, Caceres, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, , Spain
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Malmo, , Sweden
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Basel, Canton of Basel-City, Switzerland
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London, London, United Kingdom
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Brighton, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Penarth, , United Kingdom
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Sheffield, , United Kingdom
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Sheffield, , United Kingdom
Pfizer Investigational Site
Swindon, , United Kingdom
Countries
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References
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Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2521003
Identifier Type: -
Identifier Source: secondary_id
3133K1-3002
Identifier Type: -
Identifier Source: org_study_id
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