Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

Exclusion Criteria

• •An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk.
• •Patients currently residing in a nursing home.
• •Any current medical or neurological condition other than AD that could explain the patient's dementia.
• •A current diagnosis of probable or possible vascular dementia.
• •A current diagnosis of severe or unstable cardiovascular disease.
• •A current diagnosis of bradycardia (\< 50 beats per minute \[bpm\]), sick-sinus syndrome, or conduction defects.
• •Clinically significant urinary obstruction.
• •History of malignancy of any organ system within the past 5 years unless patient is verified to be in stable condition with no active metastasis.
• •Current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day.
• •A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds.
• •Taken any of the following substances (at the time of the Baseline Visit \[Visit 2\]).
• •Succinylcholine-type muscle relaxants during the previous 2 weeks.
• •Lithium during the previous 2 weeks.
• •An investigational drug during the previous 4 weeks.
• •A drug or treatment known to cause major organ system toxicity during the previous 4 weeks.
• •Rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase inhibitors (eg, tacrine, physostigmine, or pyridostigmine), or other approved treatments for Alzheimer's disease during the previous 2 weeks, with exception of stable treatment with memantine for at least 3 months before study entry (Visit 1).
• •Centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants during the previous 4 weeks.
• •Selegiline unless taken at a stable dose during the previous 4 weeks.
• •Peripheral anticholinergics not taken at a stable dose during the previous 4 weeks.
• •Extension study
• •Patients who discontinued the core study due to any reason are excluded.
• •No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.