Alzheimer's DiseasePhase 4NCT00165724
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
A Phase 4 study testing Donepezil Hydrochloride in people with Alzheimer's Disease, run by Eisai Korea Inc. at 7 sites in South Korea.
Trial summary
Open study for efficacy and safety of donepezil treatment during 48 weeks Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Donepezil Hydrochloride
- How many people
- 114 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 30 Jun 2004to 31 Dec 2006
- Phase
- Phase 4
- 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 40 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Men or women aged 40 to 90
- Diagnosis of dementia according to DSM-IV
- Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
- Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
- Patients were generally healthy and ambulatory or ambulatory aided
- Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
- Patients have useful MRI results 3 months before screening
Who cannot join
- If they have evidence of TIA or major infarction
- Epilepsy patients
- If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
- If they sensitive to acetylcholinesterase
- If they taken concomitant medication which were not allowed
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Bobath Memorial Hospital
Bundang
Bundang Seoul National University Hospital
Bundang
Changwon Fatima Hospital
Changwon
Yeungnam University Hospital
Daegu
Inha University Hospital
Incheon
Catholic University Hospital
Seoul
Eulji University Hospital
Seoul
About this study
Open study for efficacy and safety of donepezil treatment during 48 weeks
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil Hydrochloride
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog
Secondary outcomes (1)
MMSE, CDR, GDS, NPI, ADL, SSDQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study start30 Jun 2004
- Primary completion31 Jul 2006
- Study completion31 Dec 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiheed Mun, Study director, Eisai Korea Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165724
- Sponsor's protocol ID
- EKI-1002
- Status last verified
- Jun 2010
- First submitted
- 12 Sep 2005
- Last updated
- 30 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Long-term Follow-up Study (ALF Study)
- ClinicalTrials.gov ID
- NCT00165724
- Acronym / sponsor ID
- EKI-1002
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2004 (actual)
- Primary completion
- 31 Jul 2006 (actual)
- Study completion
- 31 Dec 2006 (actual)
- First posted
- 14 Sep 2005 (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.
Open study for efficacy and safety of donepezil treatment during 48 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged 40 to 90
- Diagnosis of dementia according to DSM-IV
- Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
- Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
- Patients were generally healthy and ambulatory or ambulatory aided
Key exclusion criteria (5 listed)
- If they have evidence of TIA or major infarction
- Epilepsy patients
- If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
- If they sensitive to acetylcholinesterase
- If they taken concomitant medication which were not allowed
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 |
|---|---|---|
| Donepezil Hydrochloride | Drug | – |
Primary outcome
ADAS-cog
1 secondary outcome
MMSE, CDR, GDS, NPI, ADL, SSDQ
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 30 Dec 2021.
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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.
Jiheed Mun study director
Eisai Korea Inc.
7 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 Hydrochloride in people with Alzheimer's Disease, run by Eisai Korea Inc. at 7 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 7 inclusion and 5 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
ADAS-cog. 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 30 Dec 2021.