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

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ClinicalTrials.gov Identifier: NCT02158910
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

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

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: Aricept

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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Study Type : Observational
Actual Enrollment : 2231 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Alzheimer's disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158910


Locations
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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
Sponsors and Collaborators
Eisai Korea Inc.

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Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT02158910     History of Changes
Other Study ID Numbers: ART-M082-601
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dementia
Tauopathies
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents