Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Chung-Ang University; Dong-A University; Eisai Inc.; Myongji Hospital; Seoul National University Bundang Hospital; Seoul St. Mary's Hospital
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria

• probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria

• Mini-Mental State Examination (MMSE) score of 20 or less

• General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more

• stable dose of 10mg donepezil at least 3 months before screening

• caregiver who can come together at every visit and give informations about side effects profiles should exist

• patients and caregivers accepted the study

Exclusion Criteria:

• patients receiving other concomitant acetylcholinesterase inhibitor

• uncontrolled psychiatric disorders

• drug overuse or alcohol abuse history within 5 years

• significant uncontrolled or active medical conditions

• uncontrolled epilepsy

• patients who cannot come at scheduled visits