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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 (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 (ACTION)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rivastigmine 4.6 mg/24 h (5 cm^2)
Rivastigmine 9.5 mg/24 h (10 cm^2)
Rivastigmine 13.3 mg/24 h (15 cm^2)
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, dementia, Alzheimer's type

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc
  • Northwest Neuro Specialist, PLLC
  • IHS Research Center Inc.
  • East Bay Physicians Medical Group
  • ATP Clinical Research, Inc.
  • Neuro Pain Medical Center
  • Margolin Brain Institute
  • Collaborative Neuroscience Network Inc.
  • PCND Neuroscience Research Institute Inc./The Center for Memory and Aging
  • Anderson Clinical Research
  • San Francisco Clinical Research Center
  • Neuropsychiatric Research Center of Orange County
  • California Neuroscience Research Medical Group, Inc.
  • Viking Clinical Research Center
  • Collaborative Neuroscience Network, Inc
  • Senior Care of Colorado
  • Clinical Research Studies Dept. of Clinical Science and Medical Education
  • Quantum Laboratories Memory Disorder Center
  • Brain Matters Research, Inc.
  • Neurologic Consultants, PA
  • White-Wilson Medical Center
  • MD Clinical
  • Sunrise Clinical Research, Inc
  • Compass Research, LLC
  • Integrity Research, LLC
  • Neurostudies, Inc.
  • Stedman Clinical Trials, LLC
  • Center for Clinical Trials
  • Premiere Research Institute
  • Alexian Brothers Neuroscience Institute
  • Elkhart Clinic, LLC
  • Indiana University Medical Center
  • University of Kansas Medical Center
  • MidAmerica Neuroscience Reseach Institute
  • Precise Clinical Research Solutions
  • LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic
  • J. Gary Booker, MD APMC
  • Pharmasite Research
  • The Samuel and Alexia Bratton Memory Clinic, William Hill Inc
  • Neuroscience Research of the Berkshires
  • Michigan Neurology Associates, P.C.
  • Wayne State University/Detroit Medical center
  • West Michigan Clinical Research
  • Orr & Associates Memory and Geriatric Behavioral Health Clinic
  • Neurological Research Clinic, Hattiesburg Clinic
  • The Neuroscience Center
  • Sky, LLC.
  • St. Louis University
  • Premier Psychiatric Research Institute, LLC
  • University of Nebraska Medical Center
  • Memory Enhancement Center of America, Inc.
  • Alzheimer's Research Corporation
  • NeuroCognitive Institute
  • UMDNJ-Robert Wood Johnson Medical Center
  • UMDNJ-School of Osteopathic Medicine Center
  • Memory Enhancement Center of NJ
  • Upstate Clinical Research, LLC
  • Dent Neurological Institute
  • Neurological Care of Central NY
  • Eastside Comprehensive medical Center, LLC
  • Nathan S. Kline Institute for Psychiatric Research
  • Behavioral Medical Research of Staten Island
  • Richmond Behavioral Associates
  • The Burke Rehabilitation Hospital
  • Alzheimer's Memory Center
  • Duke University Medical Center
  • Clinical Trials of America, Inc.
  • Valley Medical Research
  • University Neurology, Inc.
  • Cognitive Assessment Clinic
  • Lehigh Center for Clinical Research
  • Paramount Clinical Research
  • Department of Veterans Affairs Medical Center
  • Westmoreland Neurology associates, Inc.
  • Thomas Jefferson University
  • Research Protocol Management Specialists
  • Rhode Island Mood & Memory Research Institute
  • Psychiatric Consultants, PC
  • Volunteer Research Group
  • Jacinto Medical Group, PA
  • Future Search Trials
  • University of Texas Medical Branch
  • Innovative Clinical Trials
  • Radiant Research Inc.
  • Grayline Clinical Drug Trials
  • The Memory Clinic
  • TLC Neurology, P.L.L.C
  • UVA Neurology
  • Neurological Associates, Inc.
  • Alliance Research Group, LLC
  • The Center for Excellence in Aging and Geriatric Health
  • Internal Medicine Northwest
  • Independent Psychiatric Consultants, SC
  • Metro Medical Center
  • INSPIRA Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivastigmine 13.3 mg/24 h transdermal patch

Rivastigmine 4.6 mg/24 h transdermal patch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24
The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.
Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24
The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.

Secondary Outcome Measures

Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24
The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.
Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24
The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.
Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24
The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.
Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24
The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.
Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24
The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.

Full Information

First Posted
July 28, 2009
Last Updated
August 19, 2013
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00948766
Brief Title
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
Acronym
ACTION
Official Title
A 24 Week, Prospective, Randomized, Parallel-group, Double-blind, Multi-center Study (ENA713DUS44) Comparing the Effects of Rivastigmine Patch 15 cm^2 vs. Rivastigmine Patch 5 cm^2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION) and a 24-week Open-label Extension to Study ENA713DUS44
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, dementia, Alzheimer's type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
716 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivastigmine 13.3 mg/24 h transdermal patch
Arm Type
Experimental
Arm Description
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.
Arm Title
Rivastigmine 4.6 mg/24 h transdermal patch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine 4.6 mg/24 h (5 cm^2)
Other Intervention Name(s)
ENA713D, Exelon, Exelon patch
Intervention Description
Rivastigmine was supplied in a 5 cm^2 patch which released 4.6 mg/24 h. Patches were changed daily.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine 9.5 mg/24 h (10 cm^2)
Other Intervention Name(s)
ENA713D, Exelon, Exelon path
Intervention Description
Rivastigmine was supplied in a 10 cm^2 patch which released 9.5 mg/24 h. Patches were changed daily.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine 13.3 mg/24 h (15 cm^2)
Other Intervention Name(s)
ENA713D, Exelon, Exelon patch
Intervention Description
Rivastigmine was supplied in a 15 cm^2 patch which released 13.3 mg/24 h. Patches were changed daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.
Primary Outcome Measure Information:
Title
Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24
Description
The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.
Time Frame
Baseline of the core study to Week 24 of the core study
Title
Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24
Description
The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.
Time Frame
Baseline of the core study to Week 24 of the core study
Secondary Outcome Measure Information:
Title
Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24
Description
The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.
Time Frame
Baseline of the core study to Week 24 of the core study
Title
Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24
Description
The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.
Time Frame
Baseline of the core study to Week 24 of the core study
Title
Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24
Description
The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.
Time Frame
Baseline of the core study to Week 24 of the extension study
Title
Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24
Description
The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.
Time Frame
Baseline of the core study to Week 24 of the extension study
Title
Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24
Description
The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.
Time Frame
Baseline of the core study to Week 24 of the extension study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Northwest Neuro Specialist, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
86741
Country
United States
Facility Name
IHS Research Center Inc.
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
East Bay Physicians Medical Group
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neuro Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
PCND Neuroscience Research Institute Inc./The Center for Memory and Aging
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Viking Clinical Research Center
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Senior Care of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Clinical Research Studies Dept. of Clinical Science and Medical Education
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Quantum Laboratories Memory Disorder Center
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neurologic Consultants, PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
White-Wilson Medical Center
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Sunrise Clinical Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Integrity Research, LLC
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Neurostudies, Inc.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Center for Clinical Trials
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Reseach Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Precise Clinical Research Solutions
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
J. Gary Booker, MD APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Pharmasite Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
The Samuel and Alexia Bratton Memory Clinic, William Hill Inc
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
Neuroscience Research of the Berkshires
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Michigan Neurology Associates, P.C.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48035
Country
United States
Facility Name
Wayne State University/Detroit Medical center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
West Michigan Clinical Research
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49442
Country
United States
Facility Name
Orr & Associates Memory and Geriatric Behavioral Health Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Neurological Research Clinic, Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
The Neuroscience Center
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Sky, LLC.
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Alzheimer's Research Corporation
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
NeuroCognitive Institute
City
Mt. Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
UMDNJ-School of Osteopathic Medicine Center
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Memory Enhancement Center of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Neurological Care of Central NY
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Eastside Comprehensive medical Center, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Behavioral Medical Research of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
The Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
University Neurology, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cognitive Assessment Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Paramount Clinical Research
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Department of Veterans Affairs Medical Center
City
Coatesville
State/Province
Pennsylvania
ZIP/Postal Code
19320
Country
United States
Facility Name
Westmoreland Neurology associates, Inc.
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Protocol Management Specialists
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Psychiatric Consultants, PC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Jacinto Medical Group, PA
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Future Search Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
TLC Neurology, P.L.L.C
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
UVA Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Neurological Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
The Center for Excellence in Aging and Geriatric Health
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Internal Medicine Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Independent Psychiatric Consultants, SC
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Metro Medical Center
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
INSPIRA Clinical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25523430
Citation
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.
Results Reference
derived
Links:
URL
http://www.AlzheimersDiseaseStudy.com
Description
Online Screening Questionnaire is available

Learn more about this 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

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