Recent Updates
Recently added Catalysts

ABT-288

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jun 6, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment242
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01018875Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's DiseasePHASE2 COMPLETED 242Dec 1, 2009Feb 1, 2011Jun 6, 201821 Russia, Ukraine
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary Endpoints
MMSE: Mini Mental Status Exam
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
NPI: Neuropsychiatric Inventory
Day -1, Weeks 4,8, 12/PD
ADCS-ADL: Alzheimer's Disease Cooperative Study
Day -1, Weeks 4,8 & 12/PD
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1, Dose 1, ABT-288EXPERIMENTALLow Dose
Arm 2, Dose 2, ABT-288EXPERIMENTALHigh dose
donepezilACTIVE_COMPARATOR -
sugar pillPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ABT-288DRUGSubjects will take 4 capsules once daily for 12 weeks.
donepezilDRUGSubjects will take 4 capsules once daily for 12 weeks.
placeboDRUGSubjects will take 4 capsules once daily for 12 weeks.
Unlock Study Design Details
Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactiv...

Countries:RussiaUkraine
Unlock Eligibility Criteria