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LY2062430

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment2,065

FDA Designations

No designations recorded

Clinical trial landscape

LY2062430 · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT00904683Effect of LY2062430 on the Progression of Alzheimer's DiseaseAlzheimer's Disease
COMPLETED1,040 Analytics
NCT00905372Effect of LY2062430 on the Progression of Alzheimer's DiseaseAlzheimer's Disease
COMPLETED1,000 Analytics
PHASE3COMPLETED
Effect of LY2062430 on the Progression of Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE3COMPLETED
Effect of LY2062430 on the Progression of Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range55 Years to 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
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Frequently asked questions about LY2062430

What is LY2062430 used for?

LY2062430 is an investigational small molecule being developed for the treatment of Alzheimer's disease. It has been studied in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers. The drug is currently in Phase 3 clinical development, though all known trials have been completed.

Who makes LY2062430?

LY2062430 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has conducted multiple clinical trials of the drug for Alzheimer's disease.

What phase is LY2062430 in?

LY2062430 is in Phase 3 clinical development for Alzheimer's disease. Two Phase 3 trials have been completed, along with one Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY2062430 in?

LY2062430 has been studied in three completed trials. NCT00329082 was a Phase 2 study in mild-to-moderate Alzheimer's disease and healthy volunteers. NCT00904683 and NCT00905372 were Phase 3 trials evaluating the drug's effect on Alzheimer's disease progression, with enrollments of 1040 and 1000 participants respectively.

Is LY2062430 the same as solanezumab?

LY2062430 is the development code for solanezumab, an investigational monoclonal antibody targeting amyloid beta for Alzheimer's disease. Eli Lilly and Company has studied it in multiple clinical trials, including Phase 3 studies, though it remains investigational.