Status:
TERMINATED
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Lead Sponsor:
Pfizer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-89 years
Phase:
PHASE3
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
901 Patients enrolled
Trial Details
Trial ID
NCT00667810
Start Date
June 1 2008
End Date
August 1 2013
Last Update
January 8 2016
Active Locations (346)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
3
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
4
Jeffrey S. Gitt, DO, PC
Phoenix, Arizona, United States, 85032