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

Last updated: August 6, 2018
Sponsor: Asan Medical Center
Overall Status: Completed

Phase

3

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT02550665
JHongLee
  • Ages 45-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • probable Alzheimer's disease dementia according to National Institute onAging-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 sideeffects profiles should exist

  • patients and caregivers accepted the study

Exclusion

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

Study Design

Total Participants: 176
Study Start date:
December 01, 2014
Estimated Completion Date:
October 31, 2016

Study 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.

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

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