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Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type - NCT00948766-33060(Clinical Trial 303862)



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City:  Pompano Beach
State:  
FL
Zip Code: 33060
Conditions: Alzheimer's Disease
Purpose: This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.
Study summary:
Criteria: 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. - an Mini Mental State Examination (MMSE) score of ≥ 3 and ≤ 12 - be able to complete at least one item on the 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 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 (e.g., tacrine, physostigmine, or pyridostigmine), 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. Other protocol-defined inclusion/exclusion criteria may apply
Study is available at: Neurological Associates
Pompano Beach, FL 33060
United States

Primary Contact:
Novartis Pharmaceuticals
Phone: +1 862-778-8300
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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