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OpenTrials
Completed

NCT Number: NCT00234637

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 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Département de Gérontologie Clinique

Limoges, Cedex, 87042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine, memantine

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 7, 2005
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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