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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01849042

Acronym

ROMEO-AD

Enrollment

188

Registered

2013-05-08

Start date

2013-01-31

Completion date

2015-08-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Dementia

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.

Interventions

DRUGEbixa

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

DRUGdonepezil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
AQ-WAB(Western aphasia battery)	Six months

Secondary

Measure	Time frame
ROSA (Relevant Outcome Scale for Alzheimer's Disease)	six months

Other

Measure	Time frame
SIB-short form	six months

Countries

South Korea

Contacts

Primary ContactSeol-Heui Han, PhD. MD

alzdoc@gw.kuh.ac82-2-2030-7561

Backup ContactHyun Jeong Han, PhD. MD

neurohan@kd.ac.kr82-10-4489-8742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026