A 24-week, Multi-center, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Were Compliant to the 10 cm^2 Patch
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Rivastigmine 5 and 10 cm^2 patch
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
Intervention: Rivastigmine 5 and 10 cm^2 patch (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Were Compliant to the 10 cm^2 Patch
Time Frame: Baseline to Week 24
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study
Time Frame: Baseline to Week 24
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study
Time Frame: Baseline to Week 24
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Secondary Outcomes
- Mean Change From Baseline in the Trail-making Test Part A Score at Week 24(Baseline to Week 24)
- Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24(Baseline to Week 24)
- Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician(Baseline to Week 24)
- Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24(Baseline to Week 24)
- Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24(Baseline and Week 24)
- 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(Baseline t0 Week 24)