NCT00622713CompletedPhase 4
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
Study Overview
Brief Summary
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
Study Design
- Study Type
- Interventional
- Allocation
- Na
- 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 of at least 50 years old with a primary caregiver
- •Probable Alzheimer's disease
- •Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
- •Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
- •Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday
Exclusion Criteria
- •Patients not treated according to the product monograph for capsules
- •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)
- •History of allergy to topical products containing any of the constituents of the patches
- •Other protocol-defined inclusion/exclusion criteria may apply.
Outcomes
Primary Outcomes
Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
Time Frame: 24 weeks
The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm\^2.
Secondary Outcomes
- Clinical Global Impression of Change (CGI-C) by Physician(Baseline and week 24)
- Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score(Baseline to week 24)
- Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score(Baseline to week 24)
- Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score(Baseline to week 24)
Investigators
Study Sites (1)
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