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NCT00130338 Clinical Trial

Rivastigmine Capsules in Patients With Probable Vascular Dementia

Vascular Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00130338
Other study ID # CENA713BIA05E1
Secondary ID
Status Completed
Phase Phase 3
First received August 11, 2005
Last updated March 24, 2017
Start date February 2002
Est. completion date May 2006

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 521
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rivastigmine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
Secondary 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
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