Status:

UNKNOWN

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

Lead Sponsor:

Konkuk University Medical Center

Conditions:

Alzheimer's Disease

Dementia

Eligibility:

All Genders

50-90 years

Phase:

PHASE4

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 A...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2015

Estimated Enrollment :

188 Patients enrolled

Trial Details

Trial ID

NCT01849042

Start Date

January 1 2013

End Date

August 1 2015

Last Update

August 13 2014

Active Locations (1)

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1

Konkuk university medical center

Seoul, South Korea, 143-729

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