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Rivastigmine Capsules in Patients With Probable Vascular Dementia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00130338
Enrollment
521
Registered
2005-08-15
Start date
2002-02-28
Completion date
2006-05-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Dementia

Keywords

Dementia, Vascular, Rivastigmine, Stroke, Memory loss

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.

Interventions

DRUGRivastigmine

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026