Alzheimer's DiseasePhase 4NCT00381381
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
A Phase 4 study testing Donepezil in people with Alzheimer's Disease, run by Eisai Korea Inc. at 15 sites in South Korea.
Trial summary
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 31 May 2006to 31 Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60 - 90 years old.
- CDR: 0.5 - 2.0.
- Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
- Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
- NINCDS-ADRDA criteria: Probable AD.
Who cannot join
- Patients who have delusions and other conscious dysfunction.
- Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
- Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
- Patients with severe cerebrovascular pathology.
- Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
- Patients who have history of alcoholism or drug addiction.
- Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Seoul National University Bundang Hospital
Bundang
Hallym University Medical Center
Changwon
Kangwon National University Hospital
Chuncheon
Kunkuk University Chungju Hospital
Chungju
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Gyeonggi Province Geriatric Hospital
Gyeonggi-do
Uijeongbu St. Mary's Hospital
Gyeonggi-do
Jeju National University Hospital
Jeju City
Jeonju City Welfare Hospital
Jeonju
Gyeongsang National University Hospital
Jinju
Inje University Pusan Paik Hospital
Pusan
Kunkuk University Hospital
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil
- 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.
DonepezilDrug
Also called Aricept
2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).
Measured: 26 weeks
CERAD-K
CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.
Measured: 26 weeks
Secondary outcomes (2)
Neuropsychiatry Inventory (NPI)
NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.
Measured: 26 weeks
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study start31 May 2006
- Primary completion31 Aug 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihee Mun, Study director, Eisai Korea Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381381
- Sponsor's protocol ID
- EKI-6-004
- Status last verified
- Jul 2010
- First submitted
- 25 Sep 2006
- Last updated
- 4 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00381381
- Acronym / sponsor ID
- EKI-6-004
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2006 (actual)
- Primary completion
- 31 Aug 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Posted 27 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Donepezil |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 60 - 90 years old.
- CDR: 0.5 - 2.0.
- Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
- Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
- NINCDS-ADRDA criteria: Probable AD.
Key exclusion criteria (7 listed)
- Patients who have delusions and other conscious dysfunction.
- Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
- Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
- Patients with severe cerebrovascular pathology.
- Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
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 |
|---|---|---|
| DonepezilAlso: Aricept2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision. | Drug | 1 |
Primary outcome
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
Time frame: 26 weeks
CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).
CERAD-K
Time frame: 26 weeks
CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.
2 secondary outcomes
Neuropsychiatry Inventory (NPI)
Time frame: 26 weeks
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jihee Mun study director
Eisai Korea Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Alzheimer's Disease, run by Eisai Korea Inc. at 15 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 5 inclusion and 7 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 4 Jan 2022.