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

NCT ID: NCT01849042

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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donepezil maintain group

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

Group Type OTHER

donepezil

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

Ebixa

Intervention Type DRUG

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

donepezil

Intervention Type DRUG

Interventions

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Ebixa

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

Intervention Type DRUG

donepezil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seol-Heui Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konkuk university medical center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seol-Heui Han, PhD. MD

Role: CONTACT

82-2-2030-7561

Hyun Jeong Han, PhD. MD

Role: CONTACT

82-10-4489-8742

Facility Contacts

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Seol-Heui Han, PhD. MD

Role: primary

82-10-6309-5630

Other Identifiers

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ROMEO-AD 14394A

Identifier Type: -

Identifier Source: org_study_id

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