NCT01137526

Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.

Detailed description

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ABT-384	Subjects will take study drug once daily for 12 weeks
DRUG	donepezil	Subjects will take study drug once daily for 12 weeks.
DRUG	placebo	Subjects will take study drug once daily for 12 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-06-04
• Last updated: 2013-01-29

Locations

30 sites across 4 countries: Russia, South Africa, Ukraine, United Kingdom