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ABT-126

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Oct 31, 2014

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 Trials2
Total Enrollment708
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01549834Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsPHASE2 COMPLETED 434Mar 1, 2012Oct 1, 2013Oct 31, 201443 United States, Canada +5
NCT00948909Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's DiseasePHASE2 COMPLETED 274Oct 1, 2009Nov 1, 2010Jan 31, 201329 United States, Bulgaria +4
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Study Endpoints
Primary Endpoints
Alzheimer's Disease Assessment Scale - cognitive subscale
Measurements up through 24 weeks

An assessment tool which focuses on cognitive function and memory

ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Measurements up through 12 weeks.
Secondary Endpoints
Mini Mental Status Exam
Measurements up through 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)
Measurements up through 24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-126 Low DoseEXPERIMENTALlow dose
ABT-126 High DoseEXPERIMENTALhigh dose
sugar pillPLACEBO_COMPARATORPlacebo
A. Sugar PillPLACEBO_COMPARATOR -
B. ABT-126EXPERIMENTAL -
C. ABT-126EXPERIMENTAL -
D. donepezilACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ABT-126DRUGLow Dose
placeboDRUGPlacebo
donepezilDRUGActive comparator intervention
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Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. * The sub...

Countries:United StatesCanadaFranceGermanyGreeceSouth AfricaUnited KingdomBulgariaCzechiaSlovakia
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