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Status unknownNCT01849042ROMEO-ADUpdated Aug 13, 2014

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

A Phase 4 interventional study of Ebixa and donepezil in Alzheimer's Disease and Dementia, sponsored by Konkuk University Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-08-13.

Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer's Disease
  • Dementia

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 188 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (estimated)

Study arms

  • Other
    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 · Drug: donepezil

Interventions

  • DrugEbixa

    add-on of Ebixa oral pump already receiving donepezil with stable dosage

  • Drugdonepezil
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What researchers measure

Primary outcomes

  1. AQ-WAB(Western aphasia battery)

    Time frame: Six months

Secondary outcomes

  1. ROSA (Relevant Outcome Scale for Alzheimer's Disease)

    Time frame: six months

Other outcomes

  1. SIB-short form

    Time frame: six months

07

Study locations

1 of 1 sites recruiting
  • Konkuk university medical center
    Seoul, 143-729, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01849042
Lead sponsor
Konkuk University Medical Center
Responsible party
Seol-Heui Han (Professor, Konkuk University Medical Center) — Principal investigator
First posted
May 8, 2013
Start date
Jan 2013
Primary completion
Aug 2014 (estimated)
Completion
Aug 2015 (estimated)
Last update
Aug 13, 2014

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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