Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00428389 | Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease | PHASE3 | COMPLETED | 262 | — | — | Jan 1, 2007 | Feb 1, 2008 | Jun 11, 2014 | 23 | United States |
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...