NCT01039701

4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease

Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.

Conditions

• Mild to Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	AZD1446	capsules, oral, 3 times daily
DRUG	Placebo	capsules, oral, 3 times daily, 4 weeks

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-12-25
• Last updated: 2010-08-11

Locations

12 sites across 3 countries: Czechia, Hungary, Slovakia