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

March 6, 2017 updated by: Eisai Korea Inc.
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer's disease

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aricept Group 1
Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept
Drug: Aricept
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept
Aricept Group 2
Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept
Drug: Aricept
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-M082-601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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