Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Vascular Dementia Clinical Trial

Official title:

Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099216
• Other study ID #: CENA713BIA05
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: November 16, 2011
• Start date: August 2001
• Est. completion date: November 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• Rivastigmine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition from baseline at week 24
Primary	Global clinical impression of change from baseline at week 24
Secondary	Change in activities of daily living from baseline at week 24
Secondary	Change in behavioral symptoms from baseline at week 24
Secondary	Change in clinical staging from baseline at week 24