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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00234637
First received: October 5, 2005
Last updated: November 16, 2011
Last verified: November 2011
History of Changes

October 5, 2005
November 16, 2011
November 2003
June 2005   (final data collection date for primary outcome measure)
The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Not Provided
Complete list of historical versions of study NCT00234637 on ClinicalTrials.gov Archive Site
  • Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
  • Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
  • Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
  • Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline
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Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment

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 treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Rivastigmine, memantine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00234637
CENA713BFR05
Not Provided
Novartis
Novartis
Not Provided
Principal Investigator: Thierry Dantoine Centre Hospitalier Universitaire
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP