Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
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:
Pfizer
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
First received: June 4, 2009
Last updated: November 28, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 4, 2009 | ||||
| Last Updated Date | November 28, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety endpoints, including brain MRI [ Time Frame: 36 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety endpoints, including brain MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00916617 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination [ Time Frame: 36 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab | ||||
| Official Title ICMJE | A Multicenter, Open-Label, Multiple Dose, Parallel Group Investigation Of The Long-Term Safety, Tolerability, Reactogenicity And Efficacy Of Bapineuzumab Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer Disease | ||||
| Brief Summary | This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Alzheimer Disease | ||||
| Intervention ICMJE | Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab |
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| Study Arm (s) | Experimental: 1
5 mg/week
Intervention: Drug: bapineuzumab |
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| Publications * | Not Provided | ||||
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* 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 | ||||
| Enrollment ICMJE | 66 | ||||
| Completion Date | September 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00916617 | ||||
| Other Study ID Numbers ICMJE | 3133L1-2204, B2521009 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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