NCT02097056

Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Eisai Korea Inc. · Industry
• Sex: All
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.

Detailed description

This study consisted of pre-treatment and treatment phase. Pre-treatment phase was approximately 4 weeks including the screening and baseline process. In treatment phase, about 190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Donepezil HCL	Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-03-26
• Last updated: 2016-06-27
• Results posted: 2016-06-27

Locations

13 sites across 1 country: South Korea