Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

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.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

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.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

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.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.

The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.

Time frame: Baseline t0 Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.

Time frame: Baseline and Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.

The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.

Time frame: Baseline to Week 24

Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.