Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
NCT00667810
Last updated date
ABOUT THIS STUDY
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in
patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab
or placebo. Each patient's participation will last approximately 1.5 years.
Study Location
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 (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
- Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
- Caregiver will participate and be able to attend clinic visits with patient
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Significant neurological disease other than AD
- Major psychiatric disorder
- Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF)
shunt, or foreign metal objects in the body]
- Women of childbearing potential
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients | |||
| Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers | |||
| Brief Summary | This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Alzheimer Disease | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * |
| |||
* 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 | 901 | |||
| Original Estimated Enrollment ICMJE | 1250 | |||
| Actual Study Completion Date ICMJE | August 2013 | |||
| Actual Primary Completion Date | October 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 | Argentina, Australia, Belgium, Canada, Chile, Croatia, Finland, France, Germany, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States | |||
| Removed Location Countries | Austria, Czech Republic, Denmark, Former Serbia and Montenegro, Ireland | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00667810 | |||
| Other Study ID Numbers ICMJE | 3133K1-3000 B2521001 ( Other Identifier: Alias Study Number ) 2007-005994-79 ( EudraCT 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 | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||