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Rivastigmine Capsules in Patients With Probable Vascular Dementia

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ClinicalTrials.gov Identifier: NCT00130338
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Drug: Rivastigmine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Study Start Date : February 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD

Secondary Outcome Measures :
  1. 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00130338     History of Changes
Other Study ID Numbers: CENA713BIA05E1
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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
Neurocognitive 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
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents