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

August 12, 2014 updated by: Seol-Heui Han, Konkuk University Medical Center

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seol-Heui Han, PhD. MD
  • Phone Number: 82-2-2030-7561
  • Email: alzdoc@gw.kuh.ac

Study Contact Backup

  • Name: Hyun Jeong Han, PhD. MD
  • Phone Number: 82-10-4489-8742
  • Email: neurohan@kd.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-729
        • Recruiting
        • Konkuk University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: donepezil
Drug: Ebixa
add-on of Ebixa oral pump already receiving donepezil with stable dosage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
SIB-short form
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (ESTIMATE)

May 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROMEO-AD 14394A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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