Phase 4
Completed N=208
Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov NCT00561392 ↗Enrolled (actual)
208
Serious AEs
8.6%
Results posted
Mar 2011
Primary outcomePrimary: Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study — 74.2 Percentage of participants
Summary
This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study |
74.2 | — |
| PRIMARY Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study |
80.8 | — |
| PRIMARY Percentage of Participants Who Were Compliant to the 10 cm^2 Patch |
95.0 | — |
| SECONDARY Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24 |
1.3 | — |
| SECONDARY Mean Change From Baseline in the Trail-making Test Part A Score at Week 24 |
-8.9 | — |
| SECONDARY Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24 |
1.3 | — |
| SECONDARY Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician |
47; 25; 23; 15; 37; 12 | — |
| SECONDARY Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver |
21; 23; 16; 15; 56; 20 | — |
| SECONDARY Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24 |
0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
- MMSE (Mini-Mental State Examination) score of > 10 and < 26
- Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
- Patients who failed to benefit from previous cholinesterase inhibitor treatment
Exclusion Criteria
- Patients not treated according to the product monograph for rivastigmine capsules
- patients involved in a clinical trial
- Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
Other protocol-defined exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00561392). 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.