Alzheimer's DiseaseNCT01023867
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
A study testing donepezil in people with Alzheimer's Disease and Dementia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to Jun 2010
- Phase
- Interventional
- 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
Who may be able to join
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Who cannot join
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
Read the detailed description
The purposes of this study are:
- to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
- to help to clinicians in choosing the best treatment for patients with mixed dementia
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- donepezil
- Keywords
- Alzheimer's disease, Mixed Dementia, Donepezil, Efficacy, Adverse Event
- Medical subject headings
- Alzheimer Disease, Dementia, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezilDrug
Also called donepezil-aricept
from 5mg to 10mg, once a day, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease group | Experimental | Patients with Alzheimer's disease treated donepezil Receives: Drug: donepezil |
| Mixed Dementia group | Experimental | Patients with Mixed Dementia treated donepezil Receives: Drug: donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
Measured: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Secondary outcomes (3)
Seoul Activities of Daily Living (S-ADL)
Measured: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)
Measured: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Korean Neuropsychiatric Inventory (K-NPI)
Measured: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startMar 2007
- Primary completionJun 2010
- Study completionJun 2010
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Korea Inc.
- Responsible party
- Principal investigator, Doh Kwan Kim, Samsung Medical Center
- Investigators
- Doh Kwan Kim, PhD, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023867
- Sponsor's protocol ID
- 2007-03-039
- Status last verified
- Jan 2016
- First submitted
- 30 Nov 2009
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
- ClinicalTrials.gov ID
- NCT01023867
- Acronym / sponsor ID
- 2007-03-039
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Alzheimer's disease, Mixed Dementia, Donepezil, Efficacy, Adverse Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Eisai Korea Inc.
- Study start
- Mar 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Dec 2009 (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.
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
Detailed description
The purposes of this study are:
- to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
- to help to clinicians in choosing the best treatment for patients with mixed dementia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease group | Experimental | Drug: donepezilPatients with Alzheimer's disease treated donepezil |
| Mixed Dementia group | Experimental | Drug: donepezilPatients with Mixed Dementia treated donepezil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Key exclusion criteria (5 listed)
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
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: donepezil-ariceptfrom 5mg to 10mg, once a day, 12 months | Drug | Alzheimer's disease group, Mixed Dementia group |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
3 secondary outcomes
Seoul Activities of Daily Living (S-ADL)
Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)
Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Korean Neuropsychiatric Inventory (K-NPI)
Time frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
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 6 Jan 2016.
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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.
Doh Kwan Kim, PhD, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing donepezil in people with Alzheimer's Disease and Dementia, run by Samsung Medical Center at 1 site 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 4 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) (time frame: 13 weeks, 26 weeks, 39 weeks, 52 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 6 Jan 2016.