NCT00948909

Efficacy and Safety Study for 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-126 in Subjects With Mild-to-Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Detailed description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined: * MMSE - Mini Mental Status Exam * QoL-AD - Quality of Life - Alzheimer's Disease * CIBIC-plus - Clinician Interview-Based Impression of Change * NPI - Neuropsychiatric Inventory * CSDD - The Cornell Scale for depression in Dementia * ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Placebo intervention
DRUG	ABT-126	Experimental intervention
DRUG	donepezil	Active comparator intervention

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-07-29
• Last updated: 2013-01-31

Locations

29 sites across 6 countries: United States, Bulgaria, Czechia, Slovakia, South Africa, United Kingdom