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

Primary Purpose

Alzheimer's Disease, Dementia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ebixa
donepezil
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Konkuk university medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

donepezil maintain group

add-on Ebixa oral pump group

Arm Description

continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil 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)

Outcomes

Primary Outcome Measures

AQ-WAB(Western aphasia battery)

Secondary Outcome Measures

ROSA (Relevant Outcome Scale for Alzheimer's Disease)

Full Information

First Posted
May 6, 2013
Last Updated
August 12, 2014
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01849042
Brief Title
Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease
Acronym
ROMEO-AD
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
donepezil maintain group
Arm Type
Other
Arm Description
continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group
Arm Title
add-on Ebixa oral pump group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Ebixa
Intervention Description
add-on of Ebixa oral pump already receiving donepezil with stable dosage
Intervention Type
Drug
Intervention Name(s)
donepezil
Primary Outcome Measure Information:
Title
AQ-WAB(Western aphasia battery)
Time Frame
Six months
Secondary Outcome Measure Information:
Title
ROSA (Relevant Outcome Scale for Alzheimer's Disease)
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
SIB-short form
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seol-Heui Han, PhD. MD
Phone
82-2-2030-7561
Email
alzdoc@gw.kuh.ac
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Jeong Han, PhD. MD
Phone
82-10-4489-8742
Email
neurohan@kd.ac.kr
Facility Information:
Facility Name
Konkuk university medical center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seol-Heui Han, PhD. MD
Phone
82-10-6309-5630
Email
alzdoc@gw.kuh.ac

12. IPD Sharing Statement

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

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