Skip to main content
OpenTrials
Completed

NCT Number: NCT01023425

Clinical Trial of Donepezil Between the Naive Group and the Switching Group

To compare the clinical efficacy of donepezil between the naive group and the switching group.

Completed

Looking for future studies?

Notify Me

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

The purposes of this study are:

  • to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
  • to help to clinicians in choosing the best treatment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
  • Korean version Mini-Mental State Examination scores between 10 and 26
  • History of cognitive decline that had been gradual in onset and progressive over at least 6 months
  • A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion criteria

  • they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
  • Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
  • Cerebral injuries induced by trauma, hypoxia, and/or ischemia
  • Clinically active cerebrovascular disease; History of seizure disorder
  • Other physical conditions that required acute treatment.

Treatment and study plan

Donepezil

Drug

from 5mg to 10mg, once a day, 12 months

Other names: donepezil-aricept

Primary outcomes

  1. Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)

    Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks

Secondary outcomes

  1. Seoul Activities of Daily Living (S-ADL)

    Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks

  2. Seoul-Instrumental Activities of Daily Living (S-IADL)

    Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks

  3. Korean Neuropsychiatric Inventory (K-NPI)

    Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Eisai Korea Inc.

Registry information

Official study title

Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 2, 2009
Registry last updated
Jan 6, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.