Clinical trial NCT00099216: Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Official title: Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Dementia
Keywords: Dementia,vascular,rivastigmine,stroke,memory loss
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-10
Enrollment: 708
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 effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 50 and 85 years old
* Have contact with a responsible caregiver 3 or more days per week
* Be male or a female who is surgically sterilized or one year post menopausal

Exclusion Criteria:

* Current diagnosis of severe or unstable cardiovascular or other diseases
* Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's 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 in activities of daily living from baseline at week 24
measure: Change in behavioral symptoms from baseline at week 24
measure: Change in clinical staging from baseline at week 24
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Greensburg
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Graz
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Amiens
country: France
city: Bordeaux
country: France
city: Lille Cedex
country: France
city: Marseille
country: France
city: Montpellier Cedex
country: France
city: Toulouse
country: France
city: Tours Cedex
country: France
city: Bautzen
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Chemnitz
country: Germany
city: Eisenhuttenstadt
country: Germany
city: Erlangen
country: Germany
city: Freiburg
country: Germany
city: Luedenscheid
country: Germany
city: Osnabrueck
country: Germany
city: Ancona
country: Italy
city: Brescia
country: Italy
city: Firenze
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Vicenza
country: Italy
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Saint Cugat del Valles
country: Spain
city: Basel
country: Switzerland
city: Lausanne
country: Switzerland
city: Newcastle Upon Tyne
country: United Kingdom
state: Newcastle
city: Swindon
country: United Kingdom
state: Wiltshire
city: Bristol
country: United Kingdom
city: Clydebank
country: United Kingdom
city: East Sussex
country: United Kingdom
city: Southampton
country: United Kingdom
city: St Annes
country: United Kingdom
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142. Epub 2008 Jul 31.