Phase 4
Completed N=228
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
Source: ClinicalTrials.gov NCT00622713 ↗Enrolled (actual)
228
Serious AEs
9.6%
Results posted
Jul 2011
Primary outcomePrimary: 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 — 70.6 Percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
70.6 | — |
| SECONDARY Clinical Global Impression of Change (CGI-C) by Physician |
4.3; 13.0; 23.1; 32.2; 19.2; 5.8 | — |
| SECONDARY Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score |
3.2; 3.2; 0.1 | — |
| SECONDARY Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score |
19.2; 19.2; 0.0 | — |
| SECONDARY Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score |
2.8; 2.9; 0.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00622713). 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.