Phase 3
Completed N=262
Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
Source: ClinicalTrials.gov NCT00428389 ↗Enrolled (actual)
262
Serious AEs
8.8%
Results posted
Jun 2011
Primary outcomePrimary: Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study — 11; 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study |
11; 10 | — |
| SECONDARY Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study |
23; 15 | — |
| SECONDARY Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase |
32; 26 | — |
| SECONDARY Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25 |
3.9; 4.0; 4.1; 4.3 | — |
| SECONDARY Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study |
-0.7; -0.4; -0.5; -0.3 | — |
| SECONDARY Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study. |
-0.1; 0.4; -0.8; 0.5 | — |
| SECONDARY Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study |
-3.9; -4.2; -3.1; -4.2 | — |
Eligibility Criteria
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 to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months.
Exclusion Criteria
- Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
- Have a history of malignancy of any organ system, treated or untreated, within the past 5 years;
- Have a history within the past year or current diagnosis of cerebrovascular disease;
- Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months;
- Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease);
- Digestive problems related to peptic ulcer;
- Urinary obstruction or current severe urinary tract infection;
- Abnormal thyroid function tests;
- Low folate or Vitamin B12;
- Have a disability that may prevent the patient from completing all study requirements;
- Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch;
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00428389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.