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LY3154207

Phase 2

Lewy Body Dementia | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Jul 23, 2021

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 Trials1
Total Enrollment344
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03305809A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)PHASE2 COMPLETED 344Nov 9, 2017Jul 10, 2020Jul 23, 202177 United States, Canada +1
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Study Endpoints
Primary Endpoints
Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Baseline, Week 12

The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.

Secondary Endpoints
Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Baseline, Week 12
Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Baseline, Week 12
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received placebo administered orally once a day (QD).
10 milligram (mg) LY3154207EXPERIMENTALParticipants received 10 mg LY3154207 administered orally QD.
30 mg LY3154207EXPERIMENTALParticipants received 30 mg LY3154207 administered orally QD.
75 mg LY3154207EXPERIMENTALParticipants received 75 mg LY3154207 administered orally QD.
Interventions
NameTypeDescription
LY3154207DRUGAdministered orally.
PlaceboDRUGAdministered orally.
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment. * Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium. * Have a score on the MoCA of ...

Countries:United StatesCanadaPuerto Rico
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