Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease
NCT ID: NCT01849042
Last Updated: 2014-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
188 participants
INTERVENTIONAL
2013-01-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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donepezil maintain group
continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group
donepezil
add-on Ebixa oral pump group
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)
Ebixa
add-on of Ebixa oral pump already receiving donepezil with stable dosage
donepezil
Interventions
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Ebixa
add-on of Ebixa oral pump already receiving donepezil with stable dosage
donepezil
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
50 Years
90 Years
ALL
No
Sponsors
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Konkuk University Medical Center
OTHER
Responsible Party
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Seol-Heui Han
Professor
Locations
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Konkuk university medical center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROMEO-AD 14394A
Identifier Type: -
Identifier Source: org_study_id
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