NCT02787746

Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.

Detailed description

This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Donepezil	Eligible patients were treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the dose could be reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who could not endure the 10mg/d titration the 2nd time and were put back to 5mg/d or discontinuance of Aricept® should be considered as withdrawal from the study. There were a visit (visit 1) at week 0, the end of week 4 (visit 2) and the end of week 20 (visit 3), respectively.

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2016-06-01
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

1 site across 1 country: China