Rivastigmine Capsules in Patients With Probable Vascular Dementia

Novartis

Status and phase: Completed; Phase 3

Conditions: Vascular Dementia

Treatments: Drug: Rivastigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130338

CENA713BIA05E1

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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.

Exclusion criteria

• Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)