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

Study Overview
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Brief Summary
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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
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Rivastigmine, memantine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rivastigmine, memantine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease,, switch,, rivastigmine,, memantine