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NCT Number: NCT02550665

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

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

Other names: aricept

Primary outcomes

  1. 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)

Secondary outcomes

  1. blood WBC

    Time frame: 12 week

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

  2. blood BUN

    Time frame: 12 week

    if BUN level is above 30 mg/dL, abnormal

  3. blood Creatinine

    Time frame: 12 week

    if creatinine level is above 1.4 mg/dL, abnormal

  4. blood sodium

    Time frame: 12 week

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

  5. blood potassium

    Time frame: 12 week

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

  6. blood AST/ALT

    Time frame: 12 week

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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

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

Registry information

Official study 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

Acronym: ODESA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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