Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
NCT00916617
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
50-89 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of probable Alzheimer disease
- Completed preceding double-blind study (3133L1-2203 US)
- MMSE score > 9.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Significant brain MRI abnormalities
- Clinically important psychiatric symptoms
- History of stroke
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Advanced Information
| 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, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Alzheimer Disease | |||
| Intervention ICMJE | Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab | |||
| Study Arms ICMJE | Experimental: 1
5 mg/week Intervention: Drug: bapineuzumab | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 62 | |||
| Original Estimated Enrollment ICMJE | 120 | |||
| Actual Study Completion Date ICMJE | September 2012 | |||
| Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 50 Years to 89 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 | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00916617 | |||
| Other Study ID Numbers ICMJE | 3133L1-2204 B2521009 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||