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

NCT00099242 | Completed Phase 3

• 1 other identifier: CENA713D2320
• Study Type: interventional
• Target: 1,040
• Locations: 21 countries
• Sites: 75

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.

Conditions

Alzheimer's Disease; Dementia, Alzheimer Type

Keywords

Alzheimer's Disease; Dementia

Outcome Measures

Primary Outcomes (2)

• Change in cognition from baseline at week 24

• Global clinical impression of change from baseline at week 24

Secondary Outcomes (5)

• 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

Interventions

rivastigmine transdermal patch DRUG

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (75)

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Orange, California, 92868-3298, United States

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San Francisco, California, 94109, United States

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Boca Raton, Florida, 33486, United States

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Fort Lauderdale, Florida, 33321, United States

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Miami, Florida, 33137, United States

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Miami Beach, Florida, 33154, United States

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Port Charlotte, Florida, 33952, United States

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West Palm Beach, Florida, 33407, United States

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Snellville, Georgia, 30078, United States

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St Louis, Missouri, 63104, United States

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Omaha, Nebraska, 68131, United States

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Long Branch, New Jersey, 07740, United States

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Toms River, New Jersey, 08755, United States

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Whiting, New Jersey, 08759, United States

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Columbus, Ohio, 43215, United States

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Dayton, Ohio, 45415, United States

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Oklahoma City, Oklahoma, 73118, United States

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Greensburg, Pennsylvania, 15601, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78756, United States

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Houston, Texas, 77030, United States

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Tacoma, Washington, 98405, United States

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Santiago, Chile

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Valparaíso, Chile

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Brno, Czechia

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Brno-Bohunice, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Copenhagen, Denmark

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Glostrup Municipality, Denmark

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Hillerød, Denmark

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Kuopio, Finland

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Investigative Sites, Germany

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Guatemala City, Guatemala

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Beersheva, Israel

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Tel Aviv, Israel

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Lido di Camaiore, Italy

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Milan, Italy

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Pescara, Italy

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Guadalajara Jalisco, Mexico

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Mexico City, Mexico

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Monterrey Nuevo Leon, Mexico

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Bodø, Norway

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Oslo, Norway

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Tromsø, Norway

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Trondheim, Norway

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Lima, Peru

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Gdansk, Poland

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Lublin, Poland

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Poznan, Poland

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Szczecin, Poland

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Warsaw, Poland

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Amadora, Portugal

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Coimbra, Portugal

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Bayamón, 00959, Puerto Rico

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Moscow, Russia

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Saint Petersburg, Russia

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Bratislava, Slovakia

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Michalovce, Slovakia

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Jungbuk, South Korea

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KyungKi-province, South Korea

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Seoul, South Korea

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Gothenburg, Sweden

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Kalmar, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Ciudad Merida, Mérida, Venezuela

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Related Publications (2)

• Lefevre G, Callegari F, Gsteiger S, Xiong Y. Effects of Renal Impairment on Steady-State Plasma Concentrations of Rivastigmine: A Population Pharmacokinetic Analysis of Capsule and Patch Formulations in Patients with Alzheimer's Disease. Drugs Aging. 2016 Oct;33(10):725-736. doi: 10.1007/s40266-016-0405-y.

  PMID: 27681702 DERIVED

• Alva G, Grossberg GT, Schmitt FA, Meng X, Olin JT. Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses. Int J Geriatr Psychiatry. 2011 Apr;26(4):356-63. doi: 10.1002/gps.2534.

  PMID: 21312297 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2004
• First Posted: December 10, 2004
• Study Start: November 1, 2003
• Study Completion: January 1, 2006
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

NO (4); VE (1); US (22); GU (1); KR (3); CL (2); DK (3); ME (3); SL (2); SE (4); TW (4); PE (1); CZ (5); IT (3); PR (1); PL (5); IL (5); PT (2); RU (2); FI (1); DE (1)