Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

September 17, 2012 updated by: Novartis Pharmaceuticals

A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline

The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1584

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
      • Edmonton, Canada
        • Novartis Investigative Site
      • Greenfield Park, Canada
        • Novartis Investigative Site
      • Halifax, Canada
        • Novartis Investigative Site
      • London, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Ottawa, Canada
        • Novartis Investigative Site
      • Peterborough, Canada
        • Novartis Investigative Site
      • Quebec, Canada
        • Novartis Investigative Site
      • Regina, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
      • Winnipeg, Canada
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada
        • Novartis Investigative Site
  • France
      • Bordeaux, France
        • Novartis Investigative Site
      • Bourg en Bresse, France
        • Novartis Investigative Site
      • Caen, France
        • Novartis Investigative Site
      • Cherbourg, France
        • Novartis Investigative Site
      • Dijon, France
        • Novartis Investigative Site
      • Limoges, France
        • Novartis Investigative Site
      • Montpellier, France
        • Novartis Investigative Site
      • Nice, France
        • Novartis Investigative Site
      • Paris, France
        • Novartis Investigative Site
      • Rennes, France
        • Novartis Investigative Site
      • Rodez, France
        • Novartis Investigative Site
    • Alsace Lorraine
      • Fains Veel, Alsace Lorraine, France
        • Novartis Investigative Site
    • Burgundy
      • Dijon, Burgundy, France
        • Novartis Investigative Site
    • Champagne-Ardenne
      • Reims, Champagne-Ardenne, France
        • Novartis Investigative Site
  • Germany
      • Bad Neustadt/Saale, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Bonn, Germany
        • Novartis Investigative Site
      • Burg, Germany
        • Novartis Investigative Site
      • Duesseldorf, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Giessen, Germany
        • Novartis Investigative Site
      • Koln, Germany
        • Novartis Investigative Site
      • Krefeld, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Magdeburg, Germany
        • Novartis Investigative Site
      • Mannheim, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Muenster, Germany
        • Novartis Investigative Site
      • Nuernberg, Germany
        • Novartis Investigative Site
      • Stralsund, Germany
        • Novartis Investigative Site
      • Stuttgart, Germany
        • Novartis Investigative Site
      • Wurzburg, Germany
        • Novartis Investigative Site
  • Italy
      • Ancona, Italy
        • Novartis Investigative Site
      • Arcugnano, Italy
        • Novartis Investigative Site
      • Arezzo, Italy
        • Novartis Investigative Site
      • Bari, Italy
        • Novartis Investigative Site
      • Bologna, Italy
        • Novartis Investigative Site
      • Brescia, Italy
        • Novartis Investigative Site
      • Cagliari, Italy
        • Novartis Investigative Site
      • Catania, Italy
        • Novartis Investigative Site
      • Città di Castello, Italy
        • Novartis Investigative Site
      • Cremona, Italy
        • Novartis Investigative Site
      • Ferrara, Italy
        • Novartis Investigative Site
      • Firenze, Italy
        • Novartis Investigative Site
      • Foggia, Italy
        • Novartis Investigative Site
      • Genova, Italy
        • Novartis Investigative Site
      • La Spezia, Italy
        • Novartis Investigative Site
      • Milan, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Modena, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Padova, Italy
        • Novartis Investigative Site
      • Pavia, Italy
        • Novartis Investigative Site
      • Perugia, Italy
        • Novartis Investigative Site
      • Pisa, Italy
        • Novartis Investigative Site
      • Rho, Italy
        • Novartis Investigative Site
      • Rome, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
      • Verona, Italy
        • Novartis Investigative Site
    • Milan
      • Milano, Milan, Italy
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Palma de Mallorca, Spain
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland
        • Novartis Investigative Site
      • Biel, Switzerland
        • Novartis Investigative Site
      • Mendrisio, Switzerland
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Novartis Investigative Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Novartis Investigative Site
      • Phoenix, Arizona, United States, 85004
        • Novartis Investigative Site
      • Sun City, Arizona, United States, 85351
        • Novartis Investigative Site
    • California
      • Anaheim, California, United States, 92804
        • Novartis Investigative Site
      • Carson, California, United States, 90746
        • Novartis Investigative Site
      • Costa Mesa, California, United States, 92626
        • Novartis Investigative Site
      • Fullerton, California, United States, 92835
        • Novartis Investigative Site
      • La Habra, California, United States, 90631
        • Novartis Investigative Site
      • La Jolla, California, United States, 92037
        • Novartis Investigative Site
      • National City, California, United States, 91950
        • Novartis Investigative Site
      • Redlands, California, United States, 92374
        • Novartis Investigative Site
      • San Francisco, California, United States, 94115
        • Novartis Investigative Site
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • Novartis Investigative Site
      • Longmont, Colorado, United States, 80501
        • Novartis Investigative Site
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Novartis Investigative Site
      • Bradenton, Florida, United States, 32405
        • Novartis Investigative Site
      • Deerfield Beach, Florida, United States, 33064
        • Novartis Investigative Site
      • Delray Beach, Florida, United States, 33445
        • Novartis Investigative Site
      • Fort Lauderdale, Florida, United States, 33308
        • Novartis Investigative Site
      • Gainesville, Florida, United States, 32610
        • Novartis Investigative Site
      • Miami Beach, Florida, United States, 33140
        • Novartis Investigative Site
      • Pompano Beach, Florida, United States, 33060
        • Novartis Investigative Site
      • Port Charlotte, Florida, United States, 33952
        • Novartis Investigative Site
      • Sunrise, Florida, United States, 33351
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33407
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30341-4155
        • Novartis Investigative Site
      • Macon, Georgia, United States, 31201
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novartis Investigative Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • Novartis Investigative Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Novartis Investigative Site
      • Flushing, Michigan, United States, 48433
        • Novartis Investigative Site
      • Roseville, Michigan, United States, 48066
        • Novartis Investigative Site
      • Traverse City, Michigan, United States, 49684-2340
        • Novartis Investigative Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Novartis Investigative Site
      • Ocean Springs, Mississippi, United States, 39564
        • Novartis Investigative Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Novartis Investigative Site
      • St. Louis, Missouri, United States, 63141
        • Novartis Investigative Site
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Novartis Investigative Site
      • Nutley, New Jersey, United States, 07110
        • Novartis Investigative Site
      • Somerset, New Jersey, United States, 08873
        • Novartis Investigative Site
    • New York
      • Albany, New York, United States, 12208
        • Novartis Investigative Site
      • Syracuse, New York, United States, 13210-1853
        • Novartis Investigative Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Novartis Investigative Site
      • Morganton, North Carolina, United States, 28655
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, United States, 27103-4019
        • Novartis Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43220
        • Novartis Investigative Site
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97225
        • Novartis Investigative Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009-1957
        • Novartis Investigative Site
      • Erie, Pennsylvania, United States, 16506
        • Novartis Investigative Site
      • Greensburg, Pennsylvania, United States, 15601
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Novartis Investigative Site
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Novartis Investigative Site
      • Summerville, South Carolina, United States, 29485
        • Novartis Investigative Site
    • Tennessee
      • Brentwood, Tennessee, United States, 37027-5240
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76107
        • Novartis Investigative Site
      • Irving, Texas, United States, 75062
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Novartis Investigative Site
      • Huntington, West Virginia, United States, 25701
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease,
  • Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,
  • A primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
  • For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.

Exclusion Criteria:

  • Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
  • Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,
  • A diagnosis of probable or possible vascular dementia,
  • A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
  • A history or current diagnosis of cerebrovascular disease (e.g. stroke),
  • A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label: Rivastigmine (5 cm^2 / 10 cm^2)
Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
Drug: Rivastigmine 5 cm^2
5 cm^2 transdermal patch
Other Names:
  • Exelon®
Drug: Rivastigmine 10 cm^2
10 cm^2 transdermal patch.
Other Names:
  • Exelon®
Experimental: Double blind: Rivastigmine (10 cm^2)
Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
Drug: Rivastigmine 10 cm^2
10 cm^2 transdermal patch.
Other Names:
  • Exelon®
Drug: Placebo to 15 cm^2 patch
Placebo of rivastigmine transdermal patch 15 cm^2.
Experimental: Double blind: Rivastigmine (15 cm^2)
Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
Drug: Rivastigmine 15 cm^2
15 cm^2 transdermal patch.
Other Names:
  • Exelon®
Drug: Placebo to 10 cm^2 patch
Placebo of rivastigmine transdermal patch 10 cm^2.
Experimental: Extended open label Rivastigmine (10 cm^2)
Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
Drug: Rivastigmine 10 cm^2
10 cm^2 transdermal patch.
Other Names:
  • Exelon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period
Time Frame: Baseline and week 48 of double blind period
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.
Baseline and week 48 of double blind period
Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period
Time Frame: Baseline and week 48 of double blind period
The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.
Baseline and week 48 of double blind period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period
Time Frame: 390 days was the maximum
Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.
390 days was the maximum
Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period
Time Frame: Baseline and week 48 of double blind period
Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.
Baseline and week 48 of double blind period
Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period
Time Frame: Baseline and week 48 of double blind period
Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.
Baseline and week 48 of double blind period
Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period
Time Frame: Baseline and week 48 of double blind period
Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).
Baseline and week 48 of double blind period
Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Time Frame: 30 days after a maximum of 96 weeks treatment
30 days after a maximum of 96 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713D2340

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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