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Rivastigmine 5 cm^2 patch · 1 trial · 1 indication
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 |
|---|---|---|
| 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 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: * Be at least 50 years of age; * Have a diagnosis of probable Alzheimer's Disease; * Have an MMSE score of \> or = 10 and \< or = 24; * Must have a caregiver who is able to attend all study visits; * Have received continuous treatment with donepezil for at least 6 months prior t...
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Rivastigmine 5 cm^2 is a small molecule being developed for Alzheimer's Disease. It is an investigational treatment studied in patients with probable Alzheimer's Disease, including those showing cognitive decline. The drug is administered as a patch and is intended to address symptoms of this neurological condition.
Rivastigmine 5 cm^2 is developed by Novartis AG, a company traded under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this patch formulation in patients with Alzheimer's Disease.
Rivastigmine 5 cm^2 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are completed, and the drug remains under evaluation for Alzheimer's Disease.
Rivastigmine 5 cm^2 has been studied in two completed Phase 3 trials. NCT00428389 evaluated switching from donepezil to rivastigmine patch in 262 patients. NCT00506415 compared rivastigmine 10 and 15 cm^2 patches in 1584 patients with cognitive decline. Both trials involved Alzheimer's Disease patients aged 50 and older.
Rivastigmine 5 cm^2 refers to a specific patch size of rivastigmine. The clinical trials studied rivastigmine patches of various sizes, including 10 and 15 cm^2. The 5 cm^2 patch is one formulation within this development program for Alzheimer's Disease.