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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234637
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : November 17, 2011
Information provided by (Responsible Party):

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 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rivastigmine, memantine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Primary Outcome Measures :
  1. The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).

Secondary Outcome Measures :
  1. Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
  2. Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
  3. Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
  4. Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234637

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Département de Gérontologie Clinique
Limoges, Cedex, France, 87042
Sponsors and Collaborators
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Principal Investigator: Thierry Dantoine Centre Hospitalier Universitaire

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Responsible Party: Novartis Identifier: NCT00234637     History of Changes
Other Study ID Numbers: CENA713BFR05
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011
Keywords provided by Novartis:
Alzheimer's disease,
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents