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NCT00428389 · ClinicalTrials.gov registry record · Phase 3
Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
NCT00428389: Completed Phase 3 study, sponsored by Novartis.
NCT00428389 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 262 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00428389, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
Study Summary
This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.
Primary Outcome
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.
Interventions
- DRUG Rivastigmine 5 cm^2 transdermal patch
- DRUG Rivastigmine 10 cm^2 transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00428389 record still lists
NCT00428389 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Rivastigmine 5 cm^2 transdermal patch is the first listed.
NCT00428389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00428389 about?
NCT00428389 is a clinical study titled "Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease". This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-la...
What is the current status of trial NCT00428389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2007-01. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00428389?
The interventions under investigation include: Rivastigmine 5 cm^2 transdermal patch (DRUG), Rivastigmine 10 cm^2 transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00428389?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00428389's enrollment target sits among peer trials
262 1228th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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