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

NCT ID: NCT00099242

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Dementia, Alzheimer Type

Keywords

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Alzheimer's Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rivastigmine transdermal patch

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Orange, California, United States

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San Francisco, California, United States

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Boca Raton, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Port Charlotte, Florida, United States

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West Palm Beach, Florida, United States

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Snellville, Georgia, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Long Branch, New Jersey, United States

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Toms River, New Jersey, United States

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Whiting, New Jersey, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Greensburg, Pennsylvania, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Tacoma, Washington, 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, , 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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Countries

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United States Chile Czechia Denmark Finland Germany Guatemala Israel Italy Mexico Norway Peru Poland Portugal Puerto Rico Russia Slovakia South Korea Sweden Taiwan Venezuela

References

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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.

Reference Type DERIVED
PMID: 27681702 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21312297 (View on PubMed)

Other Identifiers

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CENA713D2320

Identifier Type: -

Identifier Source: org_study_id