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

Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs.

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.

Population: The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.

Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score 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 total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.

Time frame: Baseline, 16 weeks

Population: Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.

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 score can range from 0 to 30, with higher scores indicating better function.

Time frame: Baseline, 16 weeks

Population: Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.

Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = never took the medication as prescribed to 10 = always took the medication as prescribed.

Time frame: Week 16

Population: Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.

The following score system were used to assess skin irritation: I. Dermal response: Score 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters

Time frame: Week 16

Population: Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.

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

Time frame: 16 weeks

Population: The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.

Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score. Following scores were used to capture comments relating to patch adhesion: 0 = 90 % adhered (essentially no lift off of the skin) 1. = 75% to \< 90% adhered (some edges only lifting off of the skin) 2. = 50% to \< 75% adhered (less than half of the patch lifting off the skin) 3. = \< 50% adhered but not detached (more than half the system lifting off of the skin without falling off) 4. = the patch was completely detached. The score ranges from 1 to 4 where a higher score indicates less adhesion.

Time frame: Week 16

Population: Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.