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OpenTrials
Completed

NCT Number: NCT00099216

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

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.

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Key information

Conditions

Vascular Dementia Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine

Drug

Primary outcomes

  1. Change in cognition from baseline at week 24

  2. Global clinical impression of change from baseline at week 24

Secondary outcomes

  1. Change in activities of daily living from baseline at week 24

  2. Change in behavioral symptoms from baseline at week 24

  3. Change in clinical staging from baseline at week 24

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Dec 10, 2004
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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