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Donepezil

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Feb 8, 2011

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 Enrollment155
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01024660The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With DonepezilEARLY_PHASE1 COMPLETED 155Dec 1, 2009Jan 1, 2011Feb 8, 201118 Canada, Peru +2
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Study Endpoints
Primary Endpoints
CogState Computerized Neurological Test Battery
Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98
Secondary Endpoints
Neuropsychological Test Battery (NTB)
Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)
Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DonepezilDRUG5 mg capsule, orally, once daily, first 14 days of treatment
Placebo to match AriceptDRUGPlacebo capsule, orally, 84 days of treatment
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Eligibility Criteria
Age Range55 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria. * The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patien...

Countries:CanadaPeruPolandSouth Africa
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