NCT01849042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

May 6, 2013

Last Update Submit

August 12, 2014

Conditions

Alzheimer's DiseaseDementia

Outcome Measures

Primary Outcomes (1)

  • AQ-WAB(Western aphasia battery)

    Six months

Secondary Outcomes (1)

  • ROSA (Relevant Outcome Scale for Alzheimer's Disease)

    six months

Other Outcomes (1)

  • SIB-short form

    six months

Study Arms (2)

donepezil maintain group

OTHER

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

Drug: donepezil

add-on Ebixa oral pump group

ACTIVE COMPARATOR

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: EbixaDrug: donepezil

Interventions

EbixaDRUG

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

add-on Ebixa oral pump group
donepezilDRUG
add-on Ebixa oral pump groupdonepezil maintain group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk university medical center

Seoul, 143-729, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

MemantineDonepezil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Seol-Heui Han, PhD. MD

CONTACT

82-2-2030-7561alzdoc@gw.kuh.ac

Hyun Jeong Han, PhD. MD

CONTACT

82-10-4489-8742neurohan@kd.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 8, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

KR(1)