MedDataX Logo

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

NCT ID: NCT00506415

Last Updated: 2012-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alzheimer's Patch Cognitive Decline

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rivastigmine 5 cm^2

Intervention Type DRUG

5 cm\^2 transdermal patch

Rivastigmine 10 cm^2

Intervention Type DRUG

10 cm\^2 transdermal patch.

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.

Group Type EXPERIMENTAL

Rivastigmine 10 cm^2

Intervention Type DRUG

10 cm\^2 transdermal patch.

Placebo to 15 cm^2 patch

Intervention Type DRUG

Placebo of rivastigmine transdermal patch 15 cm\^2.

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.

Group Type EXPERIMENTAL

Rivastigmine 15 cm^2

Intervention Type DRUG

15 cm\^2 transdermal patch.

Placebo to 10 cm^2 patch

Intervention Type DRUG

Placebo of rivastigmine transdermal patch 10 cm\^2.

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.

Group Type EXPERIMENTAL

Rivastigmine 10 cm^2

Intervention Type DRUG

10 cm\^2 transdermal patch.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rivastigmine 5 cm^2

5 cm\^2 transdermal patch

Intervention Type DRUG

Rivastigmine 10 cm^2

10 cm\^2 transdermal patch.

Intervention Type DRUG

Rivastigmine 15 cm^2

15 cm\^2 transdermal patch.

Intervention Type DRUG

Placebo to 15 cm^2 patch

Placebo of rivastigmine transdermal patch 15 cm\^2.

Intervention Type DRUG

Placebo to 10 cm^2 patch

Placebo of rivastigmine transdermal patch 10 cm\^2.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exelon® Exelon® Exelon®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis investigative site

Birmingham, Alabama, United States

Site Status

Novartis investigative site

Gilbert, Arizona, United States

Site Status

Novartis investigative site

Phoenix, Arizona, United States

Site Status

Novartis investigative site

Sun City, Arizona, United States

Site Status

Novartis investigative site

Anaheim, California, United States

Site Status

Novartis investigative site

Carson, California, United States

Site Status

Novartis investigative site

Costa Mesa, California, United States

Site Status

Novartis investigative site

Fullerton, California, United States

Site Status

Novartis investigative site

La Habra, California, United States

Site Status

Novartis investigative site

La Jolla, California, United States

Site Status

Novartis investigative site

National City, California, United States

Site Status

Novartis investigative site

Redlands, California, United States

Site Status

Novartis investigative site

San Francisco, California, United States

Site Status

Novartis investigative site

Fort Collins, Colorado, United States

Site Status

Novartis investigative site

Longmont, Colorado, United States

Site Status

Novartis investigative site

Boca Raton, Florida, United States

Site Status

Novartis investigative site

Bradenton, Florida, United States

Site Status

Novartis investigative site

Deerfield Beach, Florida, United States

Site Status

Novartis investigative site

Delray Beach, Florida, United States

Site Status

Novartis investigative site

Fort Lauderdale, Florida, United States

Site Status

Novartis investigative site

Gainesville, Florida, United States

Site Status

Novartis investigative site

Miami Beach, Florida, United States

Site Status

Novartis investigative site

Pompano Beach, Florida, United States

Site Status

Novartis investigative site

Port Charlotte, Florida, United States

Site Status

Novartis investigative site

Sunrise, Florida, United States

Site Status

Novartis investigative site

West Palm Beach, Florida, United States

Site Status

Novartis investigative site

Atlanta, Georgia, United States

Site Status

Novartis investigative site

Macon, Georgia, United States

Site Status

Novartis Investigative Site

Honolulu, Hawaii, United States

Site Status

Novartis investigative site

Chicago, Illinois, United States

Site Status

Novartis investigative site

Springfield, Massachusetts, United States

Site Status

Novartis investigative site

Flint, Michigan, United States

Site Status

Novartis investigative site

Flushing, Michigan, United States

Site Status

Novartis investigative site

Roseville, Michigan, United States

Site Status

Novartis investigative site

Traverse City, Michigan, United States

Site Status

Novartis investigative site

Hattiesburg, Mississippi, United States

Site Status

Novartis investigative site

Ocean Springs, Mississippi, United States

Site Status

Novartis investigative site

Columbia, Missouri, United States

Site Status

Novartis investigative site

St Louis, Missouri, United States

Site Status

Novartis investigative site

Flemington, New Jersey, United States

Site Status

Novartis investigative site

Nutley, New Jersey, United States

Site Status

Novartis investigative site

Somerset, New Jersey, United States

Site Status

Novartis investigative site

Albany, New York, United States

Site Status

Novartis investigative site

Syracuse, New York, United States

Site Status

Novartis investigative site

Greensboro, North Carolina, United States

Site Status

Novartis investigative site

Morganton, North Carolina, United States

Site Status

Novartis investigative site

Winston-Salem, North Carolina, United States

Site Status

Novartis investigative site

Winston-Salem, North Carolina, United States

Site Status

Novartis investigative site

Canton, Ohio, United States

Site Status

Novartis investigative site

Columbus, Ohio, United States

Site Status

Novartis investigative site

Corvallis, Oregon, United States

Site Status

Novartis investigative site

Portland, Oregon, United States

Site Status

Novartis investigative site

Beaver, Pennsylvania, United States

Site Status

Novartis investigative site

Erie, Pennsylvania, United States

Site Status

Novartis investigative site

Greensburg, Pennsylvania, United States

Site Status

Novartis investigative site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis investigative site

Beaufort, South Carolina, United States

Site Status

Novartis investigative site

Summerville, South Carolina, United States

Site Status

Novartis investigative site

Brentwood, Tennessee, United States

Site Status

Novartis investigative site

Nashville, Tennessee, United States

Site Status

Novartis investigative site

Dallas, Texas, United States

Site Status

Novartis investigative site

Fort Worth, Texas, United States

Site Status

Novartis investigative site

Irving, Texas, United States

Site Status

Novartis investigative site

Charleston, West Virginia, United States

Site Status

Novartis investigative site

Huntington, West Virginia, United States

Site Status

Novartis investigative site

Toronto, Ontario, Canada

Site Status

Novartis investigative site

Calgary, , Canada

Site Status

Novartis investigative site

Edmonton, , Canada

Site Status

Novartis investigative site

Greenfield Park, , Canada

Site Status

Novartis investigative site

Halifax, , Canada

Site Status

Novartis investigative site

London, , Canada

Site Status

Novartis investigative site

Montreal, , Canada

Site Status

Novartis investigative site

Ottawa, , Canada

Site Status

Novartis investigative site

Peterborough, , Canada

Site Status

Novartis investigative site

Québec, , Canada

Site Status

Novartis investigative site

Regina, , Canada

Site Status

Novartis investigative site

Toronto, , Canada

Site Status

Novartis investigative site

Vancouver, , Canada

Site Status

Novartis investigative site

Winnipeg, , Canada

Site Status

Novartis investigative site

Fains-Véel, Alsace Lorraine, France

Site Status

Novartis investigative site

Dijon, Burgundy, France

Site Status

Novartis investigative site

Reims, Champagne-Ardenne, France

Site Status

Novartis investigative site

Bordeaux, , France

Site Status

Novartis investigative site

Bourg-en-Bresse, , France

Site Status

Novartis investigative site

Caen, , France

Site Status

Novartis investigative site

Cherbourg, , France

Site Status

Novartis investigative site

Dijon, , France

Site Status

Novartis investigative site

Limoges, , France

Site Status

Novartis investigative site

Montpellier, , France

Site Status

Novartis investigative site

Nice, , France

Site Status

Novartis investigative site

Paris, , France

Site Status

Novartis investigative site

Rennes, , France

Site Status

Novartis investigative site

Rodez, , France

Site Status

Novartis investigative site

Bad Neustadt/Saale, , Germany

Site Status

Novartis investigative site

Berlin, , Germany

Site Status

Novartis investigative site

Bonn, , Germany

Site Status

Novartis investigative site

Burg, , Germany

Site Status

Novartis investigative site

Cologne, , Germany

Site Status

Novartis investigative site

Düsseldorf, , Germany

Site Status

Novartis investigative site

Frankfurt, , Germany

Site Status

Novartis investigative site

Giessen, , Germany

Site Status

Novartis investigative site

Krefeld, , Germany

Site Status

Novartis investigative site

Leipzig, , Germany

Site Status

Novartis investigative site

Magdeburg, , Germany

Site Status

Novartis investigative site

Mannheim, , Germany

Site Status

Novartis investigative site

Marburg, , Germany

Site Status

Novartis investigative site

München, , Germany

Site Status

Novartis investigative site

Münster, , Germany

Site Status

Novartis investigative site

Nuremberg, , Germany

Site Status

Novartis investigative site

Stralsund, , Germany

Site Status

Novartis investigative site

Stuttgart, , Germany

Site Status

Novartis investigative site

Würzburg, , Germany

Site Status

Novartis investigative site

Milan, Milan, Italy

Site Status

Novartis investigative site

Ancona, , Italy

Site Status

Novartis investigative site

Arcugnano, , Italy

Site Status

Novartis investigative site

Arezzo, , Italy

Site Status

Novartis investigative site

Bari, , Italy

Site Status

Novartis investigative site

Bologna, , Italy

Site Status

Novartis investigative site

Brescia, , Italy

Site Status

Novartis investigative site

Cagliari, , Italy

Site Status

Novartis investigative site

Catania, , Italy

Site Status

Novartis investigative site

Città di Castello, , Italy

Site Status

Novartis investigative site

Cremona, , Italy

Site Status

Novartis investigative site

Ferrara, , Italy

Site Status

Novartis investigative site

Florence, , Italy

Site Status

Novartis investigative site

Foggia, , Italy

Site Status

Novartis investigative site

Genova, , Italy

Site Status

Novartis investigative site

La Spezia, , Italy

Site Status

Novartis investigative site

Milan, , Italy

Site Status

Novartis investigative site

Milan, , Italy

Site Status

Novartis investigative site

Modena, , Italy

Site Status

Novartis investigative site

Napoli, , Italy

Site Status

Novartis investigative site

Padua, , Italy

Site Status

Novartis investigative site

Pavia, , Italy

Site Status

Novartis investigative site

Perugia, , Italy

Site Status

Novartis investigative site

Pisa, , Italy

Site Status

Novartis investigative site

Rho, , Italy

Site Status

Novartis investigative site

Rome, , Italy

Site Status

Novartis investigative site

Torino, , Italy

Site Status

Novartis investigative site

Verona, , Italy

Site Status

Novartis investigative site

Barcelona, , Spain

Site Status

Novartis investigative site

Palma de Mallorca, , Spain

Site Status

Novartis investigative site

Basel, , Switzerland

Site Status

Novartis investigative site

Biel, , Switzerland

Site Status

Novartis investigative site

Mendrisio, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada France Germany Italy Spain Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Molinuevo JL, Frolich L, Grossberg GT, Galvin JE, Cummings JL, Krahnke T, Strohmaier C. Responder analysis of a randomized comparison of the 13.3 mg/24 h and 9.5 mg/24 h rivastigmine patch. Alzheimers Res Ther. 2015 Mar 8;7(1):9. doi: 10.1186/s13195-014-0088-8. eCollection 2015.

Reference Type DERIVED
PMID: 25755685 (View on PubMed)

Grossberg G, Cummings J, Frolich L, Bellelli G, Molinuevo JL, Krahnke T, Strohmaier C. Efficacy of higher dose 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in patients with mild-to-moderate Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2013 Sep;28(6):583-91. doi: 10.1177/1533317513495104.

Reference Type DERIVED
PMID: 23982674 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CENA713D2340

Identifier Type: -

Identifier Source: org_study_id