RIVastigmine In Vascular cognitivE Impairment "RIVIVE"


Phase 4 Results N/A

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