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

Eisai

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Drug: Aricept

Study type: Observational

Funder types: Industry

Identifiers

NCT02158910

ART-M082-601

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,231 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,231 participants in 2 patient groups

Aricept Group 1

Description:

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

Treatment:

Drug: Aricept

Aricept Group 2

Description:

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

Treatment:

Drug: Aricept