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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine, memantine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1). |
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Dantoine | Centre Hospitalier Universitaire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Gérontologie Clinique | Limoges | Cedex | 87042 | France |
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| 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 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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