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Also known as Rivastigmine 5 cm^2 transdermal patch, Rivastigmine 5 cm^2
Rivastigmine 5 cm^2 patch · 2 trials · 2 indications
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.
The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.
The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.
| Arm | Type | Description |
|---|---|---|
| Open label: Rivastigmine (5 cm^2 / 10 cm^2) | EXPERIMENTAL | Rivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48. |
| Double blind: Rivastigmine (10 cm^2) | EXPERIMENTAL | Rivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period. |
| Double blind: Rivastigmine (15 cm^2) | EXPERIMENTAL | Rivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period. |
| Extended open label Rivastigmine (10 cm^2) | EXPERIMENTAL | Rivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period. |
| Immediate Switch | EXPERIMENTAL | Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm\^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm\^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm\^2 patch and continued on their best tolerated dose for the remainder of the study. |
| Delayed Switch | EXPERIMENTAL | Patients randomized to the delayed switch group were switched to 5 cm\^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm\^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm\^2 patch and continued on their best tolerated dose for the remainder of the study. |
| Name | Type | Description |
|---|---|---|
| Rivastigmine 5 cm^2 | DRUG | 5 cm\^2 transdermal patch |
| Rivastigmine 10 cm^2 | DRUG | 10 cm\^2 transdermal patch. |
| Rivastigmine 15 cm^2 | DRUG | 15 cm\^2 transdermal patch. |
| Placebo to 15 cm^2 patch | DRUG | Placebo of rivastigmine transdermal patch 15 cm\^2. |
| Placebo to 10 cm^2 patch | DRUG | Placebo of rivastigmine transdermal patch 10 cm\^2. |
| Rivastigmine 5 cm^2 transdermal patch | DRUG | Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours. |
| Rivastigmine 10 cm^2 transdermal patch | DRUG | Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours. |
Inclusion Criteria: * Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease, * Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive, * A primary caregiver willing to accept responsibility for supervising treatment, assessing the patien...
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Rivastigmine 5 cm^2 patch is a transdermal formulation of rivastigmine studied for the treatment of Alzheimer Disease. It is designed to deliver rivastigmine through the skin. The clinical program for this patch size has focused on patients with Alzheimer Disease, including those showing cognitive decline and patients switching from donepezil.
Rivastigmine 5 cm^2 patch targets both butyrylcholinesterase (BCHE) and acetylcholinesterase (ACHE). It is an inhibitor of these enzymes. By inhibiting ACHE and BCHE, the patch is intended to increase cholinergic activity, which is the mechanism explored in Alzheimer Disease. The 5 cm^2 patch is a transdermal delivery form of rivastigmine.
Rivastigmine 5 cm^2 patch is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development program for this transdermal rivastigmine patch in Alzheimer Disease.
Rivastigmine 5 cm^2 patch has been studied in Phase 3 clinical development. The two recorded Phase 3 trials for this patch are both completed, and no trials are currently active. It is an investigational transdermal formulation of rivastigmine for Alzheimer Disease.
Rivastigmine 5 cm^2 patch has been evaluated in two completed Phase 3 trials: NCT00506415, a comparative efficacy, safety, and tolerability study of rivastigmine 10 and 15 cm^2 patches in Alzheimer Disease patients with cognitive decline, and NCT00428389, a safety study of switching from donepezil to rivastigmine patch in probable Alzheimer's Disease.
Yes, Rivastigmine 5 cm^2 patch is also known as Rivastigmine 5 cm^2 transdermal patch, or simply Rivastigmine 5 cm^2. These names refer to the same transdermal patch formulation developed by Novartis AG for Alzheimer Disease.