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BMS-241027

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Jul 24, 2014

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01492374Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's DiseasePHASE1 COMPLETED 40Feb 1, 2012Oct 1, 2013Jul 24, 201424 United States, Canada +3
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Study Endpoints
Primary Endpoints
Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
Within the first 70 day after first dose
Biomarker Measures: CSF levels of Tau N-terminal domain fragments
Within the first 70 day after first dose
Secondary Endpoints
Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment
Within the first 70 days after first dose
Effects of BMS-241027 on cognitive performance using computerized cognitive tests
Weeks 3, 6 and 9
Effects of BMS-241027 on connectivity MRI
Within the first 70 days after first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: BMS-241027 (0.003 mg/kg)EXPERIMENTAL -
Arm 2: BMS-241027 (0.01 mg/kg)EXPERIMENTAL -
Arm 3: BMS-241027 (0.03 mg/kg)EXPERIMENTAL -
Arm 4: Placebo matching BMS-241027EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-241027DRUGIntravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Placebo matching BMS-241027DRUGIntravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
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Eligibility Criteria
Age Range50 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria * Mini-Mental State Ex...

Countries:United StatesCanadaFranceGermanySweden
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