Clinical trial: 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 (NCT00948766)

Eligibility criteria:
Core study

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer's disease (AD) according to National Institute of
             Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders
             Association (NINCDS/ADRDA) criteria.

          -  A Mini-Mental State Examination (MMSE) score of ≥ 3 and ≤ 12.

          -  Be able to complete at least 1 item on the Severe Impairment Battery (SIB).

          -  Residing with someone in the community or in regular contact with the primary
             caregiver.

          -  Be ambulatory or ambulatory with aid.

        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

        Inclusion Criteria:

          -  Complete the double-blind phase (Week 24) of the core study.

          -  Provide, if mentally competent, a separate written informed consent prior to
             participation in the extension study. In addition, the patient's caregiver, will
             provide written informed consent prior to the patient's participation in the
             open-label extension study. If the patient is not able to provide written informed
             consent, written informed consent must be obtained from the legally authorized
             representative on the patient's behalf.

          -  Continue to reside with someone in the community or in regular contact with the
             primary caregiver; patients who reside in an assisted living facility are eligible to
             participate.

          -  Continue to have a primary caregiver willing to accept responsibility for supervising
             treatment (eg, application and removal of the patch daily at approximately the same
             time of day), assessing the condition of the patient throughout the extension study.

          -  Must be medically stable and tolerating the current dose of rivastigmine patch as
             determined by the investigator.

        Exclusion Criteria:

        Refer to the core study protocol for full details of the exclusion criteria.

          -  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.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment