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

Condition(s) targeted: Alzheimer's Disease

Intervention: Rivastigmine, memantine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Thierry Dantoine, Principal Investigator, Affiliation: Centre Hospitalier Universitaire

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Département de Gérontologie Clinique, Limoges, Cedex 87042, France

Starting date: November 2003
Ending date: June 2005
Last updated: November 19, 2007