Alzheimer's DiseaseAIDNCT02158910
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
An observational study of Alzheimer's Disease, run by Eisai Korea Inc. at 13 sites in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Aricept
- How many people
- 2,231 participants
- Where
- 13 sitesSouth Korea
- Study dates
- Mar 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alzheimer's disease
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Breast feeding
- Pregnancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Study site
Busan
Study site
Chungcheongbuk-do
Study site
Chungcheongnam-do
Study site
Daegu
Study site
Gangwon-do
Study site
Gwangju
Study site
Gyeonggji-do
Study site
Gyeongsangbuk-do
Study site
Gyeongsangnam-do
Study site
Jeju-do
Study site
Jeollabuk-do
Study site
Jeollanam-do
Study site
Seoul
About this study
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Aricept
- Keywords
- Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AriceptDrug
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept
| Study group | Role | What they receive |
|---|---|---|
| Aricept Group 1 | Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept Receives: Drug: Aricept | |
| Aricept Group 2 | Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept Receives: Drug: Aricept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158910
- Sponsor's protocol ID
- ART-M082-601
- Acronym
- AID
- Status last verified
- Feb 2017
- First submitted
- 5 Jun 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT02158910
- Acronym / sponsor ID
- AID / ART-M082-601
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,231 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aricept Group 1 | – | Drug: AriceptSubjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept |
| Aricept Group 2 | – | Drug: AriceptSubject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer's disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Breast feeding
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aricept5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept | Drug | Aricept Group 1, Aricept Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Eisai Korea Inc. at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease. (time frame: Up to 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.