A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
AID
1 other identifier
observational
2,231
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 7, 2017
February 1, 2017
1.3 years
June 5, 2014
March 6, 2017
Conditions
Keywords
Outcome Measures
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.
Up to 12 Weeks
Study Arms (2)
Aricept Group 1
Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept
Aricept Group 2
Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept
Interventions
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept
Eligibility Criteria
Patients with Alzheimer's disease
You may qualify if:
- Patients who admitted the reading and using of his/her biographical and medical data by word
- Patients who maintained Aricept dosage for at least 3 months before involved in the study
You may not qualify if:
- Hypersensitivity to the active substance or to any of the excipients
- Breast feeding
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (13)
Unknown Facility
Busan, South Korea
Unknown Facility
Chungcheongbuk-do, South Korea
Unknown Facility
Chungcheongnam-do, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Gangwon-do, South Korea
Unknown Facility
Gwangju, South Korea
Unknown Facility
Gyeonggji-do, South Korea
Unknown Facility
Gyeongsangbuk-do, South Korea
Unknown Facility
Gyeongsangnam-do, South Korea
Unknown Facility
Jeju-do, South Korea
Unknown Facility
Jeollabuk-do, South Korea
Unknown Facility
Jeollanam-do, South Korea
Unknown Facility
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 9, 2014
Study Start
March 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
March 7, 2017
Record last verified: 2017-02