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SAR110894

Phase 2

Dementia Alzheimer's Type | Small molecule | Neurology |Sanofi|Last Updated: Mar 14, 2016

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_CONTROLLEDDMC
Total Trials1
Total Enrollment291
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01266525Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on DonepezilPHASE2 COMPLETED 291Feb 1, 2011Jan 1, 2013Mar 14, 201682 United States, Australia +7
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Study Endpoints
Primary Endpoints
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
Week 4, 12, and 24
Secondary Endpoints
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Week 4, 12, and 24
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Week 4, 12, and 24
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Week 4, 12, and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR110894 - 0.5 mgEXPERIMENTALSAR110894, 0.5 mg once daily along with Donepezil.
SAR110894 - 2 mgEXPERIMENTALSAR110894, 2 mg once daily along with Donepezil.
SAR110894 - 5 mgEXPERIMENTALSAR110894, 5 mg once daily along with Donepezil.
PlaceboPLACEBO_COMPARATORPlacebo (for SAR110894) once daily along with Donepezil.
Interventions
NameTypeDescription
SAR110894DRUGPharmaceutical form: Capsule Route of administration: Oral
placebo (for SAR110894)DRUGPharmaceutical form: Capsule Route of administration: Oral
DonepezilDRUG5 mg or 10 mg once daily continued as taken before inclusion
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Eligibility Criteria
Age Range55 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites82

Inclusion criteria: * Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes). * Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit. Exclusion criteria: * Age...

Countries:United StatesAustraliaCanadaFranceGermanyItalyPolandPortugalSpain
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