NCT01539031

Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.

Conditions

• Alzheimer's Type Dementia

Interventions

Type	Name	Description
DRUG	E2020	Subjects in the Group-10 mg: Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg
DRUG	E2020	Subjects in the Group-23 mg: Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2012-02-27
• Last updated: 2023-06-18

Locations

54 sites across 1 country: Japan