Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment donepezil
Phase phase 3
Sponsor Asan Medical Center
Collaborator Dong-A University
Start date December 2014
End date July 2016
Trial size 176 participants
Trial identifier NCT02550665, JHongLee

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
donepezil 15mg during the first 4 weeks before escalation to 23mg
donepezil aricept
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
(Experimental)
alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg
donepezil aricept
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
(Active Comparator)
no titration and direct escalation to 23mg donepezil
donepezil aricept
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally

Primary Outcomes

Measure
Incidence of treatment-emergent adverse events (safety and tolerability)
time frame: Change from baseline at 4 week

Secondary Outcomes

Measure
blood WBC
time frame: 12 week
blood BUN
time frame: 12 week
blood Creatinine
time frame: 12 week
blood sodium
time frame: 12 week
blood potassium
time frame: 12 week
blood AST/ALT
time frame: 12 week
weight loss
time frame: 4 week, 8 week, 12 week
drug compliance (counting of residual drug)
time frame: 4 week, 8 week, 12 week
heart rate on Electrocardiography (ECG)
time frame: 12 week

Eligibility Criteria

Male or female participants from 45 years up to 90 years old.

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

Additional Information

Official title A Multicenter, Randomized, Open-label, Prospective Trial to Evaluate the Safety and Tolerability of Donepezil 23 mg With or Without Intermediate Dose Titration in Patients With Alzheimer's Disease Taking Donepezil Hydrochloride 10 mg
Description High dose of donepezil is currently prescribed for patients with Alzheimer's disease who showed poor response in lower dose, however the side effect profiles according to dose titration method were not clarified yet. This study aims to confirm which titration method would show better safeties and tolerabilities in the high dose donepezil treatment. Investigators include patients with moderate to severe dementia who were diagnosed as probable Alzheimer's disease and treated with donepezil 10mg at least 3 months before the study. The study duration is for 12 weeks and the titration duration is the first 4 weeks of the study. Investigators evaluate the side effects profiles and vital signs at every 4 weeks and measure blood laboratory tests at screening and the last visit.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.