A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.

The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating better function. MMSE shall be recorded at the start and end of study provided it is a part of routine clinical practic

This is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The score for each questions ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13, questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.

The total compliance is rated on an 10 point scale: 0 = "never took the medication as prescribed"; maximum of 10 = "always took the medication as prescribed."

The following score system will be used to assess skin irritation: I. Dermal response: 0 = No erythema (normal skin) = Erythema barely visible = Mild erythema = Moderate erythema = Severe erythema = Severe erythema with vesicles or blisters II. Other effects: O : Edema P : Papules (many small, red, solid, elevated lesions, surface of reaction with granular feeling) V : Small vesicles (< 0.5 cm) circumscribed elevations with visible fluid B : Large blister (> 0.5 cm) circumscribed elevations with visible fluidPu : Pustules (inflammatory small elevations containing purulent exudate) H : Hyperpigmentation (increase of the usual pigmentation limited to the patch test area) W : Weeping or oozing (may be a sign of vesiculation or blistering manifested by crusting) S : Extension of the reaction beyond patch-test site (on skin area where no test product was applied) A : Marked reaction to adhesive patch

Urine samples will be collected to assess the number of patients with UTI.

Patch adhesion to the skin will be evaluated by the caregiver. An estimate of the patch adherence will be provided and graded according to the patch adhesiveness score for the intervals between the scheduled outpatient visits. Following scores should be used to capture comments relating to patch adhesion: 0 = 90 % adhered (essentially no lift off of the skin) = 75% to < 90% adhered (some edges only lifting off of the skin) = 50% to < 75% adhered (less than half of the patch lifting off the skin) = < 50% adhered but not detached (more than half the system lifting off of the skin without falling off) = the patch was completely detached. The total score ranges from 1 to 4 where a higher score indicates less adhesion.