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This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine transdermal patch | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks. | At week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview). | At baseline, wk 12 and wk 24 | |
| Patient compliance (drug accounting) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Gosford | New South Wales | 2250 | Australia | ||
| Novartis Investigative Site |
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| During 24 weeks |
| Gosford |
| New South Wales |
| 2250 |
| Australia |
| Novartis Investigative Site | Hornsby | New South Wales | 2077 | Australia |
| Novartis Investigative Site | Randwick | New South Wales | 2031 | Australia |
| Novartis Investigative Site | Chemside | Queensland | 4032 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | Woodville | South Australia | 5011 | Australia |
| Novartis Investigative Site | Ballarat | Victoria | 3353 | Australia |
| Novartis Investigative Site | Fitzroy | Victoria | 3065 | Australia |
| Novartis Investigative Site | Heidelberg | Victoria | 3081 | Australia |
| Novartis Investigative Site | Nedlands | WA 6009 | Australia |
| Novartis Investigative Site | Johor Bahru | Johor | 81100 | Malaysia |
| Novartis Investigative Site | Seremban | Negeri Sembilan | 70300 | Malaysia |
| Novartis Investigative Site | Ipoh | Perak | 30990 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | Selangor | 50586 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Bundang | Seongnam | 463-707 | South Korea |
| Novartis Investigative Site | Seoul | 143-729 | South Korea |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Bursa | Turkey | 16059 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Konya | Turkey | 42080 | Turkey (Türkiye) |
| Novartis Investigative Site | Altunizade | 34662 | Turkey (Türkiye) |
| Novartis Investigative Site | Antalya | 07070 | Turkey (Türkiye) |
| Novartis Investigative Site | Atakum / Samsun | 55139 | Turkey (Türkiye) |
| Novartis Investigative Site | Emek / Ankara | 06510 | Turkey (Türkiye) |
| Novartis Investigative Site | Etlik / Ankara | 06018 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34303 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33079 | Turkey (Türkiye) |
| Novartis Investigative Site | Meselik / Eskisehir | 26480 | Turkey (Türkiye) |
| Novartis Investigative Site | Talas / Kayseri | 38039 | Turkey (Türkiye) |
| Novartis Investigative Site | Uskudar / Istanbul | 34668 | Turkey (Türkiye) |
| 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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