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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
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: Rivastigmine, memantine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Enrollment: 204
Study Start Date: November 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234637

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00234637     History of Changes
Other Study ID Numbers: CENA713BFR05
Study First Received: October 5, 2005
Last Updated: November 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Alzheimer's disease,
switch,
rivastigmine,
memantine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Rivastigmine
Memantine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013