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Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease (ROMEO-AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01849042
Recruitment Status : Unknown
Verified August 2014 by Seol-Heui Han, Konkuk University Medical Center.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
Seol-Heui Han, Konkuk University Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Drug: Ebixa Drug: donepezil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2015

Arm Intervention/treatment
donepezil maintain group
continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group
Drug: donepezil
Active Comparator: 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)
Drug: Ebixa
add-on of Ebixa oral pump already receiving donepezil with stable dosage

Drug: donepezil

Primary Outcome Measures :
  1. AQ-WAB(Western aphasia battery) [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. ROSA (Relevant Outcome Scale for Alzheimer's Disease) [ Time Frame: six months ]

Other Outcome Measures:
  1. SIB-short form [ Time Frame: six months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01849042

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Contact: Seol-Heui Han, PhD. MD 82-2-2030-7561
Contact: Hyun Jeong Han, PhD. MD 82-10-4489-8742

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Korea, Republic of
Konkuk university medical center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Seol-Heui Han, PhD. MD    82-10-6309-5630   
Sponsors and Collaborators
Konkuk University Medical Center
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Responsible Party: Seol-Heui Han, Professor, Konkuk University Medical Center Identifier: NCT01849042    
Other Study ID Numbers: ROMEO-AD 14394A
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents