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

Asan Medical Center176 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Alzheimer's Disease

Interventions

donepezilDRUG

using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (safety and tolerability)

adverse events (nausea, vomiting, diarrhea, anorexia, abdominal pain, headache and other unpredicted adverse events)are asked and assessed using 3 grade scale (mild, moderate, severe)

Time frame: Change from baseline at 4 week

Secondary Outcomes

blood WBC

if WBC count is below 4000/uL or above 10000/uL, abnormal

Time frame: 12 week

blood BUN

if BUN level is above 30 mg/dL, abnormal

Time frame: 12 week

blood Creatinine

if creatinine level is above 1.4 mg/dL, abnormal

Time frame: 12 week

blood sodium

if sodium level is below 135mmol/L or above 145mmol/L, abnormal

Time frame: 12 week

blood potassium

if potassium level is below 3.5mmol/L or above 5.1mmol/L, abnormal

Time frame: 12 week

blood AST/ALT

if AST or ALT level is above 50 IU/L, abnormal

Time frame: 12 week

weight loss

if the weight is decreased over 5% of body weight at screening visit, then weight loss

Time frame: 4 week, 8 week, 12 week

drug compliance (counting of residual drug)

Data from ClinicalTrials.gov

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