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

Dementia Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849042
• Other study ID #: ROMEO-AD 14394A
• Status: Recruiting
• Phase: Phase 4
• First received: May 6, 2013
• Last updated: August 12, 2014
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2014
• Source: Konkuk University Medical Center
• Contact: Seol-Heui Han, PhD. MD
• Phone: 82-2-2030-7561
• Email: alzdoc[@]gw.kuh.ac
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Konkuk university medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SIB-short form		six months	No
Primary	AQ-WAB(Western aphasia battery)		Six months	No
Secondary	ROSA (Relevant Outcome Scale for Alzheimer's Disease)		six months	No