Recent Updates
Recently added Catalysts

ABT-384

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment267

FDA Designations

No designations recorded

Clinical trial landscape

ABT-384 · 1 trial · 1 indication

Phase 2 1
NCT01137526Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED267 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about ABT-384

What is ABT-384 used for?

ABT-384 is an investigational small molecule being developed for the treatment of Alzheimer's disease. It is currently in Phase 2 clinical development and has been studied in patients with mild-to-moderate Alzheimer's disease.

Who makes ABT-384?

ABT-384 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.

What phase is ABT-384 in?

ABT-384 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is ABT-384 in?

ABT-384 has been studied in a Phase 2 clinical trial with the identifier NCT01137526. This trial was a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of ABT-384 in subjects with mild-to-moderate Alzheimer's disease. The trial enrolled 267 participants and has been completed.

How does ABT-384 work?

The mechanism of action of ABT-384 has not been disclosed. It is a small molecule being investigated for its potential effects in Alzheimer's disease, but its specific molecular target is not publicly available.