Recent Updates
Recently added Catalysts

Experimental Bapineuzumab

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: May 9, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01254773Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's DiseasePHASE2 COMPLETED 146Dec 1, 2010Mar 1, 2013May 9, 201428 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.
24 months
Secondary Endpoints
To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD
24 months
To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.
24 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bapineuzumab SC Dose 1; 2 mgEXPERIMENTAL -
Bapineuzumab SC Dose 2; 7 mgEXPERIMENTAL -
Bapineuzumab SC Dose 3; 20 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Experimental BapineuzumabDRUGBapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 89 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 18-26 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 States
Unlock Eligibility Criteria