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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099216
First received: December 10, 2004
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Vascular Dementia
Drug: Rivastigmine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in cognition from baseline at week 24
  • Global clinical impression of change from baseline at week 24

Secondary Outcome Measures:
  • 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

Enrollment: 708
Study Start Date: August 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099216

  Show 63 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00099216     History of Changes
Other Study ID Numbers: CENA713BIA05
Study First Received: December 10, 2004
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Dementia,vascular,rivastigmine,stroke,memory loss

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014