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Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

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
NCT00099216
Enrollment
708
Registered
2004-12-10
Start date
2001-08-31
Completion date
2005-11-30
Last updated
2011-11-17

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 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 Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

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

Inclusion criteria

* Between the ages of 50 and 85 years old * Have contact with a responsible caregiver 3 or more days per week * Be male or a female who is surgically sterilized or one year post menopausal

Exclusion criteria

* Current diagnosis of severe or unstable cardiovascular or other diseases * Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease

Design outcomes

Primary

MeasureTime frame
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24

Secondary

MeasureTime frame
Change in activities of daily living from baseline at week 24
Change in behavioral symptoms from baseline at week 24
Change in clinical staging from baseline at week 24

Countries

Austria, Canada, France, Germany, Italy, Russia, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026