Clinical trial NCT00099242: Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Official title: Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Dementia, Alzheimer Type
Keywords: Alzheimer's Disease
Dementia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-10
Enrollment: 1040
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in cognition from baseline at week 24
measure: Global clinical impression of change from baseline at week 24
Secondary outcomes:
measure: Change from baseline at week 24 in activities of daily living
measure: Change from baseline at week 24 in behavioral symptoms
measure: Change from baseline at week 24 in global cognitive testing
measure: Change from baseline at week 24 in executive function
measure: Change from baseline at week 24 in attention
Other outcomes:
Locations:
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Snellville
country: United States
state: Georgia
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Long Branch
country: United States
state: New Jersey
city: Manchester Township
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Greensburg
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Santiago
country: Chile
city: Valparaiso
country: Chile
city: Brno-Bohunice
country: Czechia
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Olomouc
country: Czechia
city: Prague
country: Czechia
city: Glostrup
country: Denmark
city: Hillerod
country: Denmark
city: Kobenhavn
country: Denmark
city: Kuopio
country: Finland
city: Investigative sites
country: Germany
city: Guatemala City
country: Guatemala
city: Beersheva
country: Israel
city: Hifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Lido di Camaiore
country: Italy
city: Milano
country: Italy
city: Pescara
country: Italy
city: Chungbuk
country: Korea, Republic of
city: KyungKi-province
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Guadalajara Jalisco
country: Mexico
city: Mexico D.F.
country: Mexico
city: Monterrey Nuevo Leon
country: Mexico
city: Bodo
country: Norway
city: Oslo
country: Norway
city: Tromso
country: Norway
city: Trondheim
country: Norway
city: Lima
country: Peru
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Amadora
country: Portugal
city: Coimbra
country: Portugal
city: Bayamon
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Bratislava
country: Slovakia
city: Michalovce
country: Slovakia
city: Goteborg
country: Sweden
city: Kalmar
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Ciudad Merida
country: Venezuela
state: Estado Merida
Study officials:
References:
citation: 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.
citation: 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.