Recent Updates
Recently added Catalysts

ABT-354

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Dec 11, 2013

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01908010Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsPHASE1 COMPLETED 20Jul 1, 2013Nov 1, 2013Dec 11, 20133 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Vital signs
Up to Day 10
ECG (electrocardiogram)
Up to Day 10
Neurological exam
Up to Day 10
Laboratory tests
Up to Day 10

Hematology, Chemistry, Urinalysis

Number of subject with adverse events
Up to Day 10
C-SSRS (Columbia-Suicide Severity Rating Scale)
Up to Day 10
Secondary Endpoints
Pharmacokinetic parameters
Up to Day 10
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1, low doseEXPERIMENTALABT-354
Group 2, high doseEXPERIMENTALABT-354
Interventions
NameTypeDescription
ABT-354DRUGABT-354 Low Dose
PlaceboDRUGPlacebo
Unlock Study Design Details
Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's Disease * Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening * Has a Mo...

Countries:United States
Unlock Eligibility Criteria