Recent Updates
Recently added Catalysts

LY2062430

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Dec 13, 2012

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 Trials3
Total Enrollment2,065
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00904683Effect of LY2062430 on the Progression of Alzheimer's DiseasePHASE3 COMPLETED 1,040May 1, 2009Jun 1, 2012Dec 13, 201295 United States, Australia +11
NCT00905372Effect of LY2062430 on the Progression of Alzheimer's DiseasePHASE3 COMPLETED 1,000May 1, 2009Apr 1, 2012Sep 25, 201285 United States, Argentina +3
NCT00329082Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy VolunteersPHASE2 COMPLETED 25May 1, 2006May 1, 2008Oct 7, 20096 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
Baseline, Week 80
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Baseline, 80 weeks
Safety and tolerability
1 year
Secondary Endpoints
Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Baseline, Week 80
Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score
Baseline, Week 80
Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)
Baseline, Week 80
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY2062430EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
LY2062430DRUG400 mg intravenously (IV) every 4 weeks for 80 weeks
PlaceboDRUGintravenously (IV) every 4 weeks for 80 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range55 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites95

Inclusion Criteria: * Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening * Modified Hachinski Ischemia Scale score of less than or equal to 4 * Geriatric Depression Scale score of less than or equal to 6 * A magnetic r...

Countries:United StatesAustraliaFranceGermanyItalyJapanPolandRussiaSouth KoreaSpainSwedenTaiwanUnited KingdomArgentinaBrazilCanada
Unlock Eligibility Criteria