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

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ClinicalTrials.gov Identifier: NCT00099242
Recruitment Status : Completed
First Posted : December 10, 2004
Last Update Posted : October 13, 2017
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Dementia, Alzheimer Type Drug: rivastigmine transdermal patch Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study Start Date : November 2003
Study Completion Date : January 2006

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

Secondary Outcome Measures :
  1. Change from baseline at week 24 in activities of daily living
  2. Change from baseline at week 24 in behavioral symptoms
  3. Change from baseline at week 24 in global cognitive testing
  4. Change from baseline at week 24 in executive function
  5. Change from baseline at week 24 in attention

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099242

  Hide Study 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 Beach, Florida, United States, 33154
Miami, Florida, United States, 33137
Port Charlotte, Florida, United States, 33952
West Palm Beach, Florida, United States, 33407
United States, Georgia
Snellville, Georgia, United States, 30078
United States, Missouri
Saint 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 Township, 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
Santiago, Chile
Valparaiso, Chile
Brno-Bohunice, Czechia
Brno, Czechia
Hradec Kralove, Czechia
Olomouc, Czechia
Prague, Czechia
Glostrup, Denmark
Hillerod, Denmark
Kobenhavn, Denmark
Kuopio, Finland
Investigative sites, Germany
Guatemala City, Guatemala
Beersheva, Israel
Hifa, Israel
Jerusalem, Israel
Petach Tikva, Israel
Tel Aviv, Israel
Lido di Camaiore, Italy
Milano, Italy
Pescara, Italy
Korea, Republic of
Chungbuk, Korea, Republic of
KyungKi-province, Korea, Republic of
Seoul, Korea, Republic of
Guadalajara Jalisco, Mexico
Mexico D.F., Mexico
Monterrey Nuevo Leon, Mexico
Bodo, Norway
Oslo, Norway
Tromso, Norway
Trondheim, Norway
Lima, Peru
Gdansk, Poland
Lublin, Poland
Poznan, Poland
Szczecin, Poland
Warszawa, Poland
Amadora, Portugal
Coimbra, Portugal
Puerto Rico
Bayamon, Puerto Rico, 00959
Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Bratislava, Slovakia
Michalovce, Slovakia
Goteborg, Sweden
Kalmar, Sweden
Stockholm, Sweden
Uppsala, Sweden
Kaohsiung, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Ciudad Merida, Estado Merida, Venezuela
Sponsors and Collaborators
Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00099242     History of Changes
Other Study ID Numbers: CENA713D2320
First Posted: December 10, 2004    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Novartis:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents