Alzheimer's DiseaseADOSNCT02262975
A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)
An observational study of Alzheimer's Disease, run by Eisai Korea Inc. at 26 sites in 6 countries.
Trial summary
This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 532 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Jul 2014to Aug 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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alzheimer's disease patients who have been recently prescribed with donepezil (Aricept) as monotherapy for the first time
Who may be able to join
- Greater than or equal to 50 years old and less than 90 years old
- Diagnosed as probable AD based on NINCDS-ADRDA
- Patients who have been recently prescribed with donepezil (Aricept) as monotherapy
- Patients and caregivers who signed the written informed consent from for use of personal and medical information
- Patients with caregivers who can visit the institution together
Who cannot join
- 1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
South Korea9 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gyeonggi-do
Study site
Incheon
Study site
Jeonju
Study site
Kangwon
Study site
Seongnam
Study site
Seoul
Taiwan7 sites
Study site
Bangkok
Study site
Changhua
Study site
Kaohsiung City
Study site
New Taipei City
Study site
Taichung
Study site
Tainan
Study site
Taipei
China6 sites
Study site
Beijing
Study site
Gangwon
Study site
Hong Kong
Study site
Nanjing
Study site
Shaanxi
Study site
Shanghai
About this study
This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia.
Read the detailed description
Participation in this study places no additional visit schedule, which will be determined by the investigator's judgment based on the disease progression of each subject. Investigators educate subjects to keep decided visit schedule, and collect the required information for case record from (CRF) on the visit.
- Conditions
- Alzheimer's Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| donepezil (Aricept) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment discontinuation Rate
Measured: Up to 1 year
Secondary outcomes (6)
Factors leading to donepezil treatment discontinuation
Reason for the subjects who discontinued the administration of donepezil (Aricept)
Measured: Up to 1 year
Mean change in treatment duration
Measured: Up to 1 year
Percent change in treatment regimen
Measured: Up to 1 year
Mean change in the scores of cognitive assessments test
Measured: Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]
Compliance of donepezil: Clinical Rating Scale (CRS)
CRS is a compliance scale ranged from 1 to 7. The higher score implies the higher compliance. 5 points or higher is defined as compliance, while 4 points or lower as non-compliance.
Measured: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
Compliance of donepezil: Visual Analog Scale (VAS)
VAS is a tool to determine the compliance through interview between investigators and subjects based on drug administration during previous 4 weeks. The range is from 0 to 100.
Measured: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 532 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
- NCT02262975
- Sponsor's protocol ID
- ART-M082-602
- Acronym
- ADOS
- Status last verified
- Dec 2016
- First submitted
- 26 Aug 2014
- Last updated
- 28 Dec 2016
- Results posted
- No
Publications
Shim YS, Park KH, Chen C, Dominguez JC, Kang K, Kim HJ, Hong Z, Lin YT, Chu LW, Jung S, Kim S. Caregiving, care burden and awareness of caregivers and patients with dementia in Asian locations: a secondary analysis. BMC Geriatr. 2021 Apr 7;21(1):230. doi: 10.1186/s12877-021-02178-x.
PubMed 33827446
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)
- ClinicalTrials.gov ID
- NCT02262975
- Acronym / sponsor ID
- ADOS / ART-M082-602
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Oct 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.
This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia.
Detailed description
Participation in this study places no additional visit schedule, which will be determined by the investigator's judgment based on the disease progression of each subject. Investigators educate subjects to keep decided visit schedule, and collect the required information for case record from (CRF) on the visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| donepezil (Aricept) | – | – |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alzheimer's disease patients who have been recently prescribed with donepezil (Aricept) as monotherapy for the first time
Key inclusion criteria (5 listed)
- Greater than or equal to 50 years old and less than 90 years old
- Diagnosed as probable AD based on NINCDS-ADRDA
- Patients who have been recently prescribed with donepezil (Aricept) as monotherapy
- Patients and caregivers who signed the written informed consent from for use of personal and medical information
- Patients with caregivers who can visit the institution together
Key exclusion criteria (1 listed)
- 1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment discontinuation Rate
Time frame: Up to 1 year
6 secondary outcomes
Factors leading to donepezil treatment discontinuation
Time frame: Up to 1 year
Mean change in treatment duration
Time frame: Up to 1 year
Percent change in treatment regimen
Time frame: Up to 1 year
Mean change in the scores of cognitive assessments test
Time frame: Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]
Compliance of donepezil: Clinical Rating Scale (CRS)
Time frame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
Compliance of donepezil: Visual Analog Scale (VAS)
Time frame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
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 28 Dec 2016.
- Derived from this study: PubMed 33827446Shim YS, Park KH, Chen C, Dominguez JC, Kang K, Kim HJ, Hong Z, Lin YT, Chu LW, Jung S, Kim S. Caregiving, care burden and awareness of caregivers and patients with dementia in Asian locations: a secondary analysis. BMC Geriatr. 2021 Apr 7;21(1):230. doi: 10.1186/s12877-021-02178-x.
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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.
26 sites in 6 countries: 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 26 sites in 6 countries.
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 5 inclusion and 1 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea, Taiwan, China, Thailand, Philippines and 1 more country. 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?
Treatment discontinuation Rate (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262975, which also lists 1 linked publication.
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 28 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.