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PF-04494700 - Low Dose Arm

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Aug 20, 2009

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_CONTROLLED
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00141661A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's PatientsPHASE2 COMPLETED 67Oct 1, 2005Jun 1, 2006Aug 20, 200912 United States
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Study Endpoints
Primary Endpoints
Safety Measures include Adverse Events
Every Visit
Laboratory Tests
Every Office Visit
12-Lead Electrocardiogram
Every Office Visit
24-Hour 12-Lead Serial ECGs
Baseline, Study End
Secondary Endpoints
Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Baseline, Visit 5, Study End
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Screening Visit, Baseline, Study End
Pharmacokinetic Profile
Baseline and Every Office Visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low Dose ArmEXPERIMENTAL -
High Dose ArmEXPERIMENTAL -
Placebo ControlPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-04494700 - Low Dose ArmDRUG30 mg loading dose for 6 days, followed by 10 mg daily
PF-04494700 - High Dose ArmDRUG60 mg loading dose for 6 days, followed by 20 mg daily
Placebo ComparatorDRUGMatching placebo.
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Diagnosis of probably Alzheimer's disease for at least 1 year. * Mini Mental State Exam (MMSE) score between 12-26 at screening. * Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months. Exc...

Countries:United States
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