Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Diseas

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

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: 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 ]

Original Primary Outcome: Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)

Current Secondary Outcome:

• Clinical Global Impression of Change (CGI-C) by Physician [ Time Frame: Baseline and week 24 ]
  The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:"very much improved", "much improved", "slightly improved", "unchanged", "slightly worsened", "much worsened" and "very much worsened".
• Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score [ Time Frame: Baseline to week 24 ]
  The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.
• Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline to week 24 ]
  The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.
• Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score [ Time Frame: Baseline to week 24 ]
  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.

Original Secondary Outcome:

• Mini-Mental State Examination score at baseline, week 8, 24 and premature discontinuation
• Clinical Global Impression of Change (week 8, 24 and premature discontinuation)
• 4 scores from the Activities of Daily Living (budget, transport, drug management, phone) at baseline, week 8 and week 24 or at premature discontinuation
• At any time : Adverse events, vital signs, physical examination

Dates:
Date Received: February 14, 2008
Date Started: January 2008
Date Completion:
Last Updated: June 27, 2011
Last Verified: June 2011