A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Alzheimer Disease |
| Intervention |
Drug: Bapineuzumab 0.5 mg/kg |
| Enrollment | 494 |
Participant Flow
| Recruitment Details | This study was conducted at 147 centers in 19 countries. The study was terminated early by the sponsor on 06 August 2012. Subjects who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit. |
| Pre-assignment Details |
| Arm/Group Title | Placebo/Bapineuzumab | Bapineuzumab/Bapineuzumab |
|---|---|---|
 Arm/Group Description |
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195. | Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. |
| Period Title: Overall Study | ||
| Started | 216 | 276 |
| Treated | 215 | 275 |
| Completed | 0 | 2 |
| Not Completed | 216 | 274 |
| Reason Not Completed | ||
| Lack of Efficacy | 3 | 6 |
| Adverse Event | 17 | 12 |
| Withdrawal by Subject | 19 | 25 |
| Physician Decision | 3 | 3 |
| Death | 3 | 1 |
| Discontinuation of Study by Sponsor | 164 | 217 |
| Protocol Violation | 0 | 1 |
| Failed to Return | 1 | 1 |
| Lost to Follow-up | 1 | 1 |
| Loss of Caregiver | 0 | 3 |
| Other | 4 | 4 |
| Recurrent Episode of vasogenic edema | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo/Bapineuzumab | Bapineuzumab/Bapineuzumab | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. | Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 215 | 275 | 490 | |
|
Baseline Analysis Population Description |
The safety population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 215 participants | 275 participants | 490 participants | |
| 71.4 (8.14) | 72.1 (7.47) | 71.8 (7.77) | ||
|
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 215 participants | 275 participants | 490 participants |
| < 65 years | 44 | 42 | 86 | |
| >= 65 years | 171 | 233 | 404 | |
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 215 participants | 275 participants | 490 participants | |
| Female |
135 62.8%
|
186 67.6%
|
321 65.5%
|
|
| Male |
80 37.2%
|
89 32.4%
|
169 34.5%
|
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title: | Pfizer ClinicalTrials.gov Call Center |
| Organization: | Pfizer, Inc. |
| Phone: | 1-800-718-1021 |
| EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00998764 |
| Other Study ID Numbers: |
3133K1-3003 B2521004 ( Other Identifier: Alias Study Number ) 2009-015080-13 ( EudraCT Number ) |
| First Submitted: | October 16, 2009 |
| First Posted: | October 20, 2009 |
| Results First Submitted: | October 15, 2013 |
| Results First Posted: | January 1, 2016 |
| Last Update Posted: | January 1, 2016 |