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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine, memantine

Primary Measures

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

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Thierry Dantoine Principal Investigator Centre Hospitalier Universitaire  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234637

Study ID Number: CENA713BFR05

ClinicalTrials.gov Identifier: NCT00234637

Health Authority: France: Afssaps - French Health Products Safety Agency