Alzheimer's DiseasePhase 4ROMEO-ADNCT01849042
Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease
A Phase 4 study testing Ebixa and donepezil in people with Alzheimer's Disease and Dementia, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Ebixa and donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Aug 2015
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria
- MMSE score equal to or less than 20
- Brain CT or MRI scan performed within the past 12 months
- living or having regular visit at least three times a week from caregiver
- able to visit outpatient clinic and to perform cognitive function test
- already taking stable dose of donepezil for 3 months prior to screening
- subject and caregiver who signed informed consent
Who cannot join
- involved in another clinical trial within 4 weeks prior to screening
- severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure
- bradycardia (pulse rate less than 50bpm), sick sinus syndrome
- any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)
- severe auditory or visual disturbance
- other degenerative disease or psychosis
- taken any drug used for the treatment of Alzheimer's disease or dementia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk university medical center
Seoul, 143-729
Seol-Heui Han, PhD. MD, 82-10-6309-5630, alzdoc@gw.kuh.ac
About this study
Official title: A Multicenter, Randomized, Open-label, Prospective Study to Estimate the add-on Effects of Memantine as Ebixa Oral Pump on Language in Moderate to Severe Alzheimer's Disease Patients Already Receiving Donepezil.
This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Ebixa, donepezil
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbixaDrug
add-on of Ebixa oral pump already receiving donepezil with stable dosage
donepezilDrug
| Study group | Role | What they receive |
|---|---|---|
| donepezil maintain group | Other | continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group Receives: Drug: donepezil |
| add-on Ebixa oral pump group | Active comparator | Ebixa dosage titration (5mg per day for 1week, then 10mg per day for 1week, then 15mg per day for 1week, then up to 20mg per day) add-on already taking donepezil (5mg or 10mg per day) Receives: Drug: Ebixa; Drug: donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
AQ-WAB(Western aphasia battery)
Measured: Six months
Secondary outcomes (1)
ROSA (Relevant Outcome Scale for Alzheimer's Disease)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2015 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seol-Heui Han, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849042
- Sponsor's protocol ID
- ROMEO-AD 14394A
- Acronym
- ROMEO-AD
- Status last verified
- Aug 2014
- First submitted
- 6 May 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Prospective Study to Estimate the add-on Effects of Memantine as Ebixa Oral Pump on Language in Moderate to Severe Alzheimer's Disease Patients Already Receiving Donepezil.
- ClinicalTrials.gov ID
- NCT01849042
- Acronym / sponsor ID
- ROMEO-AD / ROMEO-AD 14394A
- Conditions
- Alzheimer's Disease, Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 May 2013 (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 will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| donepezil maintain group | Other | Drug: donepezilcontinue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group |
| add-on Ebixa oral pump group | Active comparator | Drug: Ebixa, Drug: donepezilEbixa dosage titration (5mg per day for 1week, then 10mg per day for 1week, then 15mg per day for 1week, then up to 20mg per day) add-on already taking donepezil (5mg or 10mg per day) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria
- MMSE score equal to or less than 20
- Brain CT or MRI scan performed within the past 12 months
- living or having regular visit at least three times a week from caregiver
- able to visit outpatient clinic and to perform cognitive function test
Key exclusion criteria (7 listed)
- involved in another clinical trial within 4 weeks prior to screening
- severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure
- bradycardia (pulse rate less than 50bpm), sick sinus syndrome
- any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)
- severe auditory or visual disturbance
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 |
|---|---|---|
| Ebixaadd-on of Ebixa oral pump already receiving donepezil with stable dosage | Drug | add-on Ebixa oral pump group |
| donepezil | Drug | add-on Ebixa oral pump group, donepezil maintain group |
Primary outcome
AQ-WAB(Western aphasia battery)
Time frame: Six months
1 secondary outcome
ROSA (Relevant Outcome Scale for Alzheimer's Disease)
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ebixa and donepezil in people with Alzheimer's Disease and Dementia, run by Konkuk University 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 7 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: status not confirmed, as of the sponsor's last update on 13 Aug 2014. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seol-Heui Han, PhD. MD (82-2-2030-7561, alzdoc@gw.kuh.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AQ-WAB(Western aphasia battery) (time frame: Six months). 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 13 Aug 2014.