A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
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ClinicalTrials.gov Identifier: NCT00998764 |
Recruitment Status :
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.)
First Posted : October 20, 2009
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2009 | |||
First Posted Date ICMJE | October 20, 2009 | |||
Results First Submitted Date ICMJE | October 15, 2013 | |||
Results First Posted Date ICMJE | January 1, 2016 | |||
Last Update Posted Date | January 1, 2016 | |||
Study Start Date ICMJE | December 2009 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants Reporting a Serious Adverse Event [ Time Frame: Up to Week 195 ] Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients | |||
Official Title ICMJE | 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 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww. | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer Disease | |||
Intervention ICMJE | 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
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Study Arms ICMJE | Experimental: Bapineuzumab 0.5 mg/kg
Intervention: Drug: Bapineuzumab 0.5 mg/kg
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
494 | |||
Original Estimated Enrollment ICMJE |
800 | |||
Actual Study Completion Date ICMJE | November 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 51 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Chile, Finland, France, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States | |||
Removed Location Countries | Mexico | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00998764 | |||
Other Study ID Numbers ICMJE | 3133K1-3003 B2521004 ( Other Identifier: Alias Study Number ) 2009-015080-13 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Pfizer | |||
Original Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Current Study Sponsor ICMJE | Pfizer | |||
Original Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |