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| Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Alzheimer Disease |
- Drug: bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65. Other Name: AAB-001 - Drug: bapineuzumab
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65. Other Name: AAB-001 - Drug: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
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- Experimental: Bapineuzumab 0.5 mg/kg
Intervention: Drug: bapineuzumab - Experimental: Bapineuzumab 1.0 mg/kg
Intervention: Drug: bapineuzumab - Placebo Comparator: Placebo
Intervention: Drug: placebo
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- 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.
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| Terminated |
| 901 |
| 1250 |
| August 2013 |
| October 2012 (Final data collection date for primary outcome measure) |
Inclusion Criteria: - 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: - 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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| Sexes Eligible for Study: | All |
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| 50 Years to 89 Years (Adult, Older Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
| Austria, Czech Republic, Denmark, Former Serbia and Montenegro, Ireland |
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| NCT00667810 |
3133K1-3000
B2521001 ( Other Identifier: Alias Study Number )
2007-005994-79 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
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| Pfizer |
| December 2015 |
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