Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
Phase 4
Completed
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00234637
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Département de Gérontologie Clinique
🇫🇷Limoges, Cedex, France