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Trial NCT00948766

Resource URI: http://static.linkedct.org/resource/trials/NCT00948766
PropertyValue
linkedct:acronym ACTION
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/59234>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/59235>
linkedct:brief_title Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type
linkedct:condition <http://static.linkedct.org/resource/condition/832>
linkedct: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
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 50 Years
linkedct:enrollment 712 (xsd:int)
linkedct:firstreceived_date July 28, 2009
linkedct:id NCT00948766
rdfs:label Trial NCT00948766
linkedct:lastchanged_date August 24, 2009
linkedct:lead_sponsor_agency Novartis
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linkedct:nct_id NCT00948766
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A 24 Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm2 vs. Rivastigmine Patch 5 cm2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION).
linkedct:org_study_id CENA713DUS44
linkedct:overall_contact_last_name Novartis Pharmaceuticals
linkedct:overall_contact_phone +1 862-778-8300
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/44246>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00948766>
linkedct:phase Phase 4
linkedct:primary_completion_date April 2012
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/38334>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/10550>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/21815>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/22607>
linkedct:source Novartis
linkedct:start_date July 2009
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date August 2009