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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Dong-A University

Myongji Hospital

Seoul National University Bundang Hospital

Seoul St. Mary's Hospital

Chung-Ang University

Eisai Inc.

Information provided by (Responsible Party):

Jae-Hong Lee, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT02550665

First received: September 10, 2015

Last updated: July 15, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2015

Last Updated Date

July 15, 2016

Start Date ^ICMJE

December 2014

Estimated Primary Completion Date

July 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Change from baseline at 4 week ]

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02550665 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

blood WBC [ Time Frame: 12 week ]
if WBC count is below 4000/uL or above 10000/uL, abnormal
blood BUN [ Time Frame: 12 week ]
if BUN level is above 30 mg/dL, abnormal
blood Creatinine [ Time Frame: 12 week ]
if creatinine level is above 1.4 mg/dL, abnormal
blood sodium [ Time Frame: 12 week ]
if sodium level is below 135mmol/L or above 145mmol/L, abnormal
blood potassium [ Time Frame: 12 week ]
if potassium level is below 3.5mmol/L or above 5.1mmol/L, abnormal
blood AST/ALT [ Time Frame: 12 week ]
if AST or ALT level is above 50 IU/L, abnormal
weight loss [ Time Frame: 4 week, 8 week, 12 week ]
if the weight is decreased over 5% of body weight at screening visit, then weight loss
drug compliance (counting of residual drug) [ Time Frame: 4 week, 8 week, 12 week ]
if the (number of prescribed drugs - number of residual drugs)/ number of prescribed drugs is below 80%, then consider as low compliance, if compliance is between 80-100% then consider as good compliance
heart rate on Electrocardiography (ECG) [ Time Frame: 12 week ]
checking whether heart rate on ECG is normal because donepezil can cause bradycardia; if the heart rate is decreased below 50, then write down as bradycardia

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: donepezil

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

Other Name: aricept

Study Arms

Experimental: donepezil 15mg titration
donepezil 15mg during the first 4 weeks before escalation to 23mg

Intervention: Drug: donepezil
Experimental: donepezil 10mg & 23 mg alternating
alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg

Intervention: Drug: donepezil
Active Comparator: no titration of donepezil
no titration and direct escalation to 23mg donepezil

Intervention: Drug: donepezil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

176

Estimated Completion Date

October 2016

Estimated Primary Completion Date

July 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

45 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02550665

Other Study ID Numbers ^ICMJE

JHongLee

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Jae-Hong Lee, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Dong-A University
Myongji Hospital
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Chung-Ang University
Eisai Inc.

Investigators ^ICMJE

Not Provided

PRS Account

Asan Medical Center

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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