|Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients|
|A Phase Iii, 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 Carriers|
|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.|
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.
- Lacey L, Bobula J, Rüdell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.
|October 2012 (Final data collection date for primary outcome measure)|
- Diagnosis of probable AD, with MMSE score of 16-26, and brain 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.
- Significant neurological disease other than AD, or a major psychiatric disorder
- Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
- Woman of childbearing potential
|Sexes Eligible for Study:||All|
|50 Years to 88 Years (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Argentina, Australia, Austria, Belgium, Chile, Croatia, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States|
|Czech Republic, Denmark, Ireland, Jamaica|
B2521002 ( Other Identifier: Alias Study Number )
2007-005995-14 ( EudraCT Number )
|Study Director:||Pfizer CT.gov Call Center||Pfizer|