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ABT-384

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jan 29, 2013

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment267
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01137526Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's DiseasePHASE2 COMPLETED 267May 1, 2010Jul 1, 2011Jan 29, 201330 Russia, South Africa +2
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Study Endpoints
Primary Endpoints
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
12 Weeks
Secondary Endpoints
Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12
12 Weeks
Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12
12 Weeks
Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-384 Dose 1EXPERIMENTAL -
ABT-384 Dose 2EXPERIMENTAL -
donepezilACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ABT-384DRUGSubjects will take study drug once daily for 12 weeks
donepezilDRUGSubjects will take study drug once daily for 12 weeks.
placeboDRUGSubjects will take study drug once daily for 12 weeks
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Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject. 2. Subject is male or female between the ages...

Countries:RussiaSouth AfricaUkraineUnited Kingdom
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