Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099242
First received: December 10, 2004
Last updated: December 17, 2007
Last verified: December 2007
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099242
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Hide Study LocationsLocations
| 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 Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Rivastigmine Cholinesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013