RIVastigmine In Vascular cognitivE Impairment (NCT00669344) | Clinical Trial Compass
CompletedPhase 4
RIVastigmine In Vascular cognitivE Impairment
Singapore50 participantsStarted 2006-02
Plain-language 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.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the comparative change from baseline between treatment and placebo arms in the Ten Point Clock Drawing Test as well as Color Trails 1 and 2.