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CompletedNCT02158910AIDUpdated Mar 7, 2017

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

An observational study in Alzheimer's Disease, sponsored by Eisai Korea Inc.. Completed at 13 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Eisai Korea Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,231
Sex
All
01

Study summary

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

Read the detailed description

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.

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Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 2,231 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eisai Korea Inc. is the lead sponsor of 30 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Alzheimer's disease

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  1. Hypersensitivity to the active substance or to any of the excipients
  2. Breast feeding
  3. Pregnancy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,231 participants (actual)
Patient registry
No

Groups and cohorts

  • Aricept Group 1

    Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept

    Drug: Aricept

  • Aricept Group 2

    Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept

    Drug: Aricept

Interventions

  • DrugAricept

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

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What researchers measure

Primary outcomes

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

    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.

    Time frame: Up to 12 Weeks

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Study locations

13 sites
  • Busan, Korea, Republic of
  • Chungcheongbuk-do, Korea, Republic of
  • Chungcheongnam-do, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gangwon-do, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Gyeonggji-do, Korea, Republic of
  • Gyeongsangbuk-do, Korea, Republic of
  • Gyeongsangnam-do, Korea, Republic of
  • Jeju-do, Korea, Republic of
  • Jeollabuk-do, Korea, Republic of
  • Jeollanam-do, Korea, Republic of
  • Seoul, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02158910
Lead sponsor
Eisai Korea Inc.
Responsible party
Sponsor
First posted
Jun 9, 2014
Start date
Mar 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Mar 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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