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Clinical Trials/NCT00099216
NCT00099216CompletedPhase 3

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

Novartis Pharmaceuticals63 sites in 8 countries708 target enrollmentStarted: August 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
708
Locations
63
Primary Endpoint
Change in cognition from baseline at week 24
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in cognition from baseline at week 24

Global clinical impression of change from baseline at week 24

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (63)

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Efficacy and Safety of Rivastigmine... | Clinical Trial