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SR57667B

Phase 2

Alzheimer Disease | Small molecule | Neurology |Sanofi|Last Updated: Dec 23, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment890
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00285025Study of the Effect of SR57667B in Patients With Alzheimer's DiseasePHASE2 COMPLETED 500Mar 1, 2005Sep 1, 2005Feb 1, 2006 -
NCT00285077Long-Term Safety Extension With SR57667B in Patients With Alzheimer's DiseasePHASE2 COMPLETED 390Mar 1, 2004Nov 1, 2006Dec 23, 20087 Canada, Denmark +5
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Study Endpoints
Primary Endpoints
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
Adverse events recorded quarterly.
Secondary Endpoints
MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SR57667BDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male / female outpatients. * Age \> 50 years at screening. * Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score \> 12 and \< 26. * Untreated or treated for a minimum of 6...

Countries:CanadaDenmarkFinlandFranceGermanySouth AfricaSweden
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