Status:

COMPLETED

Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

Lead Sponsor:

Novartis

Conditions:

Alzheimer's Disease

Eligibility:

All Genders

50+ years

Phase:

PHASE4

Brief Summary

This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine tr...

Eligibility Criteria

Inclusion

  • Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
  • Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
  • Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion

  • Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial

Key Trial Info

Start Date :

November 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2005

Estimated Enrollment :

204 Patients enrolled

Trial Details

Trial ID

NCT00234637

Start Date

November 1 2003

End Date

June 1 2005

Last Update

November 17 2011

Active Locations (1)

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Département de Gérontologie Clinique

Limoges, Cedex, France, 87042