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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099242
First received: December 10, 2004
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Dementia, Alzheimer Type
Drug: rivastigmine transdermal patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in cognition from baseline at week 24
  • Global clinical impression of change from baseline at week 24

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1040
Study Start Date: November 2003
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099242

  Hide Study Locations
Locations
United States, California
Orange, California, United States, 92868-3298
San Francisco, California, United States, 94109
United States, 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
United States, Georgia
Snellville, Georgia, United States, 30078
United States, Missouri
St. Louis, Missouri, United States, 63104
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Long Branch, New Jersey, United States, 07740
Manchester, New Jersey, United States, 08759
Toms River, New Jersey, United States, 08755
United States, Ohio
Columbus, Ohio, United States, 43215
Dayton, Ohio, United States, 45415
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
Greensburg, Pennsylvania, United States, 15601
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78756
Houston, Texas, United States, 77030
United States, Washington
Tacoma, Washington, United States, 98405
Chile
Santiago, Chile
Valparaiso, Chile
Czech Republic
Brno, Czech Republic
Brno-Bohunice, Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
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
Venezuela
Ciudad Merida, Estado Merida, Venezuela
Sponsors and Collaborators
Novartis
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00099242     History of Changes
Other Study ID Numbers: CENA713D2320
Study First Received: December 10, 2004
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Alzheimer's Disease
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Rivastigmine
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014