Rivastigmine Capsules in Patients With Probable Vascular Dementia

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00130338

Collaborator

(none)

521

Enrollment

50.9

Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this research study is to evaluate, in the open-label extension phase, 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Dementia	Drug: Rivastigmine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

521 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD []

Secondary Outcome Measures

52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.