RIVastigmine In Vascular cognitivE Impairment

Launched by SINGAPORE GENERAL HOSPITAL · Apr 29, 2008

Keywords

ClinConnect Summary

Methodology: This is a 24-week, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Cognitive Impairment Not Dementia due to cerebrovascular disease.

During the screening period, patients will be evaluated for CIND by means of neuropsychological tests establishing cognitive impairment following stroke or resulting from subcortical ischemic vascular disease (diagnosed by MRI) AND exclusion of dementia by DSM-IV criteria. At baseline, eligible patients will be evaluated for additional inclusion/exclusion criteria, vital signs, MMSE, Ten Point ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • male and female patients, age 55-85
• • outpatients, living with a caregiver
• • Rankin score \<=3
• • Diagnosis of Cognitive Impairment Not Dementia due to cerebrovascular disease
• • Post-stroke cognitive impairment
• • Cognitive impairment documented by neuropsychological evaluation within 6 months of index stroke
• Exclusion Criteria:
• • Advanced, severe, and unstable disease of any type that may interfere with the efficacy evaluations or put the subject at special risk
• • A current diagnosis of active uncontrolled seizure disorder
• • A current diagnosis of active peptic ulceration
• • A current diagnosis of severe and unstable cardiovascular disease
• • A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, atrioventricular block)
• • A current diagnosis of unstable angina
• • MI within the last 6 months
• • DSM IV current diagnosis of dementia
• • DSM IV current diagnosis of major depression (patients may be included if currently being treated on an antidepressant and stabilized after 3 months)
• • A disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty)
• • A known exaggerated pharmacological sensitivity or hypersensitivity to acetylcholinesterase inhibitors or to other cholinergic compounds
• * Ingestion of any of the following:
• • an investigational drug in the past four weeks
• • metrifonate in the last 3 months
• • a drug or treatment known to cause major organ system toxicity during the past four weeks
• • other cholinergic drugs (eg succinylcholine type muscle relaxants) during the past two weeks
• • anticholinergics prior to baseline
• • acetylcholinesterase inhibitors in the past 3 months
• • Women of childbearing potential