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ABT-354

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ABT-354 · 1 trial · 1 indication

Phase 1 1
NCT01908010Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsAlzheimer's Disease
COMPLETED20 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Alzheimer's DiseaseUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range55 Years to 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
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Frequently asked questions about ABT-354

What is ABT-354 used for in Alzheimer's Disease?

ABT-354 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is intended for patients with mild-to-moderate Alzheimer's Disease who are on stable doses of acetylcholinesterase inhibitors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ABT-354 target?

The molecular target of ABT-354 has not been disclosed. As a small molecule in early clinical development for Alzheimer's Disease, its specific mechanism of action is not publicly available. The drug is being studied for its safety, tolerability, and pharmacokinetics in patients with mild-to-moderate Alzheimer's Disease.

Who makes ABT-354?

ABT-354 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical research on this investigational drug for Alzheimer's Disease, with the drug currently in Phase 1 development.

What phase is ABT-354 in?

ABT-354 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for safety, tolerability, and pharmacokinetics in patients with mild-to-moderate Alzheimer's Disease, and remains in early-stage clinical testing.

What clinical trials is ABT-354 in?

ABT-354 has one completed clinical trial, identified as NCT01908010. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of ABT-354 in subjects with mild-to-moderate Alzheimer's Disease on stable doses of acetylcholinesterase inhibitors. The trial enrolled 20 participants in the United States and was double-blind, randomized, and controlled.