Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Alzheimer's Disease, Dementia

Intervention / Treatment
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* Drug: Ebixa
* Drug: donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: donepezil maintain group<br>continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group | Drug: donepezil<br> <br> |
| Active Comparator: add-on Ebixa oral pump group<br>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) | Drug: Ebixa<br>* add-on of Ebixa oral pump already receiving donepezil with stable dosage<br>Drug: donepezil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AQ-WAB(Western aphasia battery) |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSA (Relevant Outcome Scale for Alzheimer's Disease) |  | six months |