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

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ClinicalTrials.gov 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
Sponsor:
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01849042


Contacts
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Contact: Seol-Heui Han, PhD. MD 82-2-2030-7561 alzdoc@gw.kuh.ac
Contact: Hyun Jeong Han, PhD. MD 82-10-4489-8742 neurohan@kd.ac.kr

Locations
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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    alzdoc@gw.kuh.ac   
Sponsors and Collaborators
Konkuk University Medical Center

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Responsible Party: Seol-Heui Han, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01849042     History of Changes
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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents