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Donepezil

Phase 3

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Mar 5, 2015

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 Trials2
Total Enrollment294
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00630851A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing HomesPHASE3 COMPLETED 249Oct 1, 2002Oct 1, 2004Mar 5, 201553 Sweden,
NCT00006399Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's DiseasePHASE2 COMPLETED 45Sep 1, 1999Mar 1, 2004Jan 15, 20091 United States
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Study Endpoints
Primary Endpoints
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
Month 6
Secondary Endpoints
Change from baseline in SIB total score
Month 3
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Months 3 and 6
Change from inclusion in Mini Mental State Examination (MMSE) total score
Month 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Donepezil (Aricept)DRUGDonepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
PlaceboDRUGMatching placebo tablets orally once daily for 6 months
DonepezilDRUG -
EstrogenDRUG -
ProgesteroneDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Probable or possible Alzheimer's disease * Living in skilled nursing home Exclusion Criteria: * Other types of dementia or psychiatric or neurologic disorders * Musculoskeletal disease

Countries:SwedenUnited States
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