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bapineuzumab

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: Nov 25, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment2,686
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00574132Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)PHASE3 COMPLETED 1,331Dec 1, 2007Jun 1, 2012Nov 25, 2013251 United States, Austria +2
NCT00575055Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)PHASE3 COMPLETED 1,121Dec 1, 2007Apr 1, 2012Nov 25, 2013186 United States
NCT00112073AAB-001 in Patients With Mild to Moderate Alzheimer's DiseasePHASE2 COMPLETED 234Apr 1, 2005Dec 1, 2008Mar 14, 201226 United States
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Study Endpoints
Primary Endpoints
Cognitive and Functional
18 months
safety assessments
18 months
Secondary Endpoints
Cognitive and Global
18 months
Imaging and biochemical biomarkers of disease status
18 months
blood levels of administered study drug
18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bapineuzumab 0.5 mg/kgEXPERIMENTALinfusion every 13 weeks for a total of 6 infusions
Placebo ControlPLACEBO_COMPARATORinfusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kgEXPERIMENTALinfusion every 13 weeks for a total of 6 infusions.
Placebo DosePLACEBO_COMPARATORinfusion every 13 weeks for a total of 6 infusions.
0.15 mg/kg active bapineuzumabEXPERIMENTAL -
0.15 mg/kg placeboPLACEBO_COMPARATOR -
0.5 mg/kg active bapineuzumabEXPERIMENTAL -
0.5 mg/kg placeboPLACEBO_COMPARATOR -
1.0 mg/kg active bapineuzumabEXPERIMENTAL -
1.0 mg/kg placeboPLACEBO_COMPARATOR -
2.0 mg/kg active bapineuzumabEXPERIMENTAL -
2.0 mg/kg placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Bapineuzumab 0.5 mg/kgDRUGinfusion every 13 weeks for a total of 6 infusions
Placebo ControlDRUGgiven by infusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kgDRUGinfusion every 13 weeks for a total of 6 infusions
bapineuzumabDRUGIV, Q13w
placeboOTHERIV Q13w
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Eligibility Criteria
Age Range50 Years — 88 Years
SexALL
Healthy VolunteersNo
Study Sites251

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 16-26 inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Stable doses of medications (cholinesterase inhibitors and memantine allowed) * Caregiv...

Countries:United StatesAustriaCanadaGermany
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