RIVastigmine In Vascular cognitivE Impairment

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND) to evaluate efficacy, safety and tolerability in Asian patients. The hypothesis is that patients receiving Rivastigmine would improve in executive functioning domains.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborators: National Neuroscience Institute; Novartis
• Treatments: Rivastigmine

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