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
NCT ID: NCT00948766
Last Updated: 2013-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
716 participants
INTERVENTIONAL
2009-07-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rivastigmine 13.3 mg/24 h transdermal patch
In the core study, patients were titrated to the rivastigmine 13.3 mg/24 h dose in 2 steps. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-8, patients received rivastigmine 9.5 mg/24 h and placebo. For Weeks 9-24, patients received rivastigmine 13.3 mg/24 h and placebo. In the extension study, all patients were switched to rivastigmine 9.5 mg/24 h for a 4-week titration period and were then titrated up to 13.3 mg/24 h for a further 20 weeks of treatment.
Rivastigmine 4.6 mg/24 h (5 cm^2)
Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily.
Rivastigmine 9.5 mg/24 h (10 cm^2)
Rivastigmine was supplied in a 10 cm\^2 patch which released 9.5 mg/24 h. Patches were changed daily.
Rivastigmine 13.3 mg/24 h (15 cm^2)
Rivastigmine was supplied in a 15 cm\^2 patch which released 13.3 mg/24 h. Patches were changed daily.
Placebo
Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.
Rivastigmine 4.6 mg/24 h transdermal patch
In the core study, patients received rivastigmine 4.6 mg/24 h daily. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-24, patients received rivastigmine 4.6 mg/24 h and placebo. No patients received this treatment in the extension study.
Rivastigmine 4.6 mg/24 h (5 cm^2)
Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily.
Placebo
Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.
Interventions
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Rivastigmine 4.6 mg/24 h (5 cm^2)
Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily.
Rivastigmine 9.5 mg/24 h (10 cm^2)
Rivastigmine was supplied in a 10 cm\^2 patch which released 9.5 mg/24 h. Patches were changed daily.
Rivastigmine 13.3 mg/24 h (15 cm^2)
Rivastigmine was supplied in a 15 cm\^2 patch which released 13.3 mg/24 h. Patches were changed daily.
Placebo
Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
* 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
* 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.
50 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc
Tempe, Arizona, United States
Northwest Neuro Specialist, PLLC
Tucson, Arizona, United States
IHS Research Center Inc.
Conway, Arkansas, United States
East Bay Physicians Medical Group
Berkeley, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Neuro Pain Medical Center
Fresno, California, United States
Margolin Brain Institute
Fresno, California, United States
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States
PCND Neuroscience Research Institute Inc./The Center for Memory and Aging
Poway, California, United States
Anderson Clinical Research
Redlands, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Viking Clinical Research Center
Temecula, California, United States
Collaborative Neuroscience Network, Inc
Torrance, California, United States
Senior Care of Colorado
Aurora, Colorado, United States
Clinical Research Studies Dept. of Clinical Science and Medical Education
Boca Raton, Florida, United States
Quantum Laboratories Memory Disorder Center
Deerfield Beach, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Neurologic Consultants, PA
Fort Lauderdale, Florida, United States
White-Wilson Medical Center
Fort Walton Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Integrity Research, LLC
Pensacola, Florida, United States
Neurostudies, Inc.
Port Charlotte, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Center for Clinical Trials
Venice, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MidAmerica Neuroscience Reseach Institute
Lenexa, Kansas, United States
Precise Clinical Research Solutions
Manhattan, Kansas, United States
LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic
Shreveport, Louisiana, United States
J. Gary Booker, MD APMC
Shreveport, Louisiana, United States
Pharmasite Research
Baltimore, Maryland, United States
The Samuel and Alexia Bratton Memory Clinic, William Hill Inc
Easton, Maryland, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States
Michigan Neurology Associates, P.C.
Clinton Township, Michigan, United States
Wayne State University/Detroit Medical center
Detroit, Michigan, United States
West Michigan Clinical Research
Muskegon, Michigan, United States
Orr & Associates Memory and Geriatric Behavioral Health Clinic
Saint Paul, Minnesota, United States
Neurological Research Clinic, Hattiesburg Clinic
Hattiesburg, Mississippi, United States
The Neuroscience Center
Ocean Springs, Mississippi, United States
St. Louis University
St Louis, Missouri, United States
Sky, LLC.
St Louis, Missouri, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
Alzheimer's Research Corporation
Paterson, New Jersey, United States
UMDNJ-School of Osteopathic Medicine Center
Stratford, New Jersey, United States
Memory Enhancement Center of NJ
Toms River, New Jersey, United States
Upstate Clinical Research, LLC
Albany, New York, United States
Dent Neurological Institute
Amherst, New York, United States
Neurological Care of Central NY
Liverpool, New York, United States
Eastside Comprehensive medical Center, LLC
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
The Burke Rehabilitation Hospital
White Plains, New York, United States
Alzheimer's Memory Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States
Valley Medical Research
Centerville, Ohio, United States
University Neurology, Inc.
Cincinnati, Ohio, United States
Cognitive Assessment Clinic
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, United States
Department of Veterans Affairs Medical Center
Coatesville, Pennsylvania, United States
Westmoreland Neurology associates, Inc.
Greensburg, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Psychiatric Consultants, PC
Franklin, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Jacinto Medical Group, PA
Baytown, Texas, United States
Future Search Trials
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Radiant Research Inc.
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
TLC Neurology, P.L.L.C
Arlington, Virginia, United States
UVA Neurology
Charlottesville, Virginia, United States
Neurological Associates, Inc.
Richmond, Virginia, United States
Alliance Research Group, LLC
Richmond, Virginia, United States
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, United States
Internal Medicine Northwest
Tacoma, Washington, United States
Independent Psychiatric Consultants, SC
Waukesha, Wisconsin, United States
Metro Medical Center
Bayamón, , Puerto Rico
INSPIRA Clinical Research
San Juan, , Puerto Rico
Countries
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References
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Grossberg GT, Farlow MR, Meng X, Velting DM. Evaluating high-dose rivastigmine patch in severe Alzheimer's disease: analyses with concomitant memantine usage as a factor. Curr Alzheimer Res. 2015;12(1):53-60. doi: 10.2174/1567205011666141218122835.
Other Identifiers
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CENA713DUS44
Identifier Type: -
Identifier Source: org_study_id
NCT01054755
Identifier Type: -
Identifier Source: nct_alias