Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

October 12, 2017 updated by: Novartis Pharmaceuticals
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1040

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

  • Chile
      • Santiago, Chile
      • Valparaiso, Chile
  • Czechia
      • Brno, Czechia
      • Brno-Bohunice, Czechia
      • Hradec Kralove, Czechia
      • Olomouc, Czechia
      • Prague, Czechia
  • Denmark
      • Glostrup, Denmark
      • Hillerod, Denmark
      • Kobenhavn, Denmark
  • Finland
      • Kuopio, Finland
  • Germany
      • Investigative sites, Germany
  • Guatemala
      • Guatemala City, Guatemala
  • Israel
      • Beersheva, Israel
      • Hifa, Israel
      • Jerusalem, Israel
      • Petach Tikva, Israel
      • Tel Aviv, Israel
  • Italy
      • Lido di Camaiore, Italy
      • Milano, Italy
      • Pescara, Italy
  • Korea, Republic of
      • Chungbuk, Korea, Republic of
      • KyungKi-province, Korea, Republic of
      • Seoul, Korea, Republic of
  • Mexico
      • Guadalajara Jalisco, Mexico
      • Mexico D.F., Mexico
      • Monterrey Nuevo Leon, Mexico
  • Norway
      • Bodo, Norway
      • Oslo, Norway
      • Tromso, Norway
      • Trondheim, Norway
  • Peru
      • Lima, Peru
  • Poland
      • Gdansk, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Portugal
      • Amadora, Portugal
      • Coimbra, Portugal
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
  • Russian Federation
      • Moscow, Russian Federation
      • Saint-Petersburg, Russian Federation
  • Slovakia
      • Bratislava, Slovakia
      • Michalovce, Slovakia
  • Sweden
      • Goteborg, Sweden
      • Kalmar, Sweden
      • Stockholm, Sweden
      • Uppsala, Sweden
  • Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Tao-Yuan, Taiwan
  • United States
    • California
      • Orange, California, United States, 92868-3298
      • San Francisco, California, United States, 94109
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Fort Lauderdale, Florida, United States, 33321
      • Miami, Florida, United States, 33137
      • Miami Beach, Florida, United States, 33154
      • Port Charlotte, Florida, United States, 33952
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Snellville, Georgia, United States, 30078
    • Missouri
      • Saint Louis, Missouri, United States, 63104
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
      • Manchester Township, New Jersey, United States, 08759
      • Toms River, New Jersey, United States, 08755
    • Ohio
      • Columbus, Ohio, United States, 43215
      • Dayton, Ohio, United States, 45415
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78756
      • Houston, Texas, United States, 77030
    • Washington
      • Tacoma, Washington, United States, 98405
  • Venezuela
    • Estado Merida
      • Ciudad Merida, Estado Merida, Venezuela

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:

  • Diagnosis of dementia of the Alzheimer's type
  • Males, and females who are surgically sterile or one year postmenopausal
  • A primary caregiver willing to accept responsibility for supervising the treatment

Exclusion Criteria:

  • Any condition (other than Alzheimer's) that could explain patient's dementia
  • An advanced, severe or unstable disease that may put the patient at special risk
  • Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24

Secondary Outcome Measures

Outcome Measure
Change from baseline at week 24 in activities of daily living
Change from baseline at week 24 in behavioral symptoms
Change from baseline at week 24 in global cognitive testing
Change from baseline at week 24 in executive function
Change from baseline at week 24 in attention

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

November 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713D2320

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.

Clinical Trials on Dementia, Alzheimer Type

Clinical Trials on rivastigmine transdermal patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe