Rivastigmine Capsules in Patients With Probable Vascular Dementia

Novartis521 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

521

Conditions

Vascular Dementia

Interventions

RivastigmineDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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