NCT01690195

Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

Detailed description

This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ABT-126	See arm description

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-09-21
• Last updated: 2021-08-02

Locations

39 sites across 7 countries: United States, Canada, France, Germany, Greece, South Africa, United Kingdom