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Completed

NCT Number: NCT02158910

A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Busan, South Korea

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About this study

This is an observational study to systematically investigate domestic patients with Alzheimer's disease to figure out the safety under a situation of the use of Donepezil HCl 23mg. Additionally, if the dose of Donepezil HCl increase, there is need to examine the safety of Donepezil HCl 23mg in depth for patients with Alzheimer's disease by comparing aspects of occurring adverse events by the type of Donepezil HCl increase.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who admitted the reading and using of his/her biographical and medical data by word
  • Patients who maintained Aricept dosage for at least 3 months before involved in the study

Exclusion criteria

  • Hypersensitivity to the active substance or to any of the excipients
  • Breast feeding
  • Pregnancy

Treatment and study plan

Aricept

Drug

5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

Primary outcomes

  1. Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.

    Time frame: Up to 12 Weeks

    The aspects of adverse events between those who have increased Aricept dosage from 5mg to 10mg and those who have increased Aricept dosage from 10mg to 23mg will be compared. The subjects will be observed at least more than 12 weeks after Aricept administration. The patients who have obtained safety information through a visit after Aricept administration at least once will be selected as the subjects who can be assessed under the status of use.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Acronym: AID

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2014
Registry last updated
Mar 7, 2017

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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