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AVE1625

Phase 1

Alzheimer Disease | Small molecule | Neurology |Sanofi|Last Updated: Dec 19, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00380302Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.PHASE1 COMPLETED 162Sep 1, 2006Jul 1, 2007Dec 19, 20085 United States, France +3
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Study Endpoints
Primary Endpoints
Safety and tolerability throughout the study:adverse events collected by spontaneous report
physical examination and neurological assessment
vital sign monitoring, clinical laboratories, and ECGs.
Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.
Secondary Endpoints
Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AVE1625DRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * The diagnosis of Alzheimer's disease * Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI) * Mild to moderate range of disease; not too severe Exclusion Criteria: * Severe or unstable medical diseases * Neurological disorder ...

Countries:United StatesFranceItalyNetherlandsSweden
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