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

Alzheimer's Disease Clinical Trial

— AID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158910
• Other study ID #: ART-M082-601
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: March 6, 2017
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2231
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Aricept
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 Weeks