Rivastigmine for Delirium
(RIVA-AM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests rivastigmine to determine its effectiveness in treating antimuscarinic delirium, a type of confusion and agitation caused by certain poisons. Since the usual treatment, physostigmine, is difficult to obtain, researchers aim to assess whether rivastigmine can serve as a suitable alternative. Participants will receive either rivastigmine or a placebo (a pill with no active drug) to evaluate which better alleviates symptoms. This trial suits individuals diagnosed with antimuscarinic delirium who experience significant confusion and agitation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that rivastigmine is likely to be safe for humans?
Research has shown that rivastigmine is generally safe for use. In other studies, some patients taking rivastigmine experienced common side effects such as nausea, vomiting, and dizziness, which were usually mild. Rivastigmine has also been used in patients with Alzheimer's disease, providing insights into its safety. However, using rivastigmine for antimuscarinic delirium (AMD) remains under investigation, so more research is needed to fully understand its safety and effectiveness for this condition.12345
Why do researchers think this study treatment might be promising for delirium?
Rivastigmine is unique because it targets delirium through a mechanism that is different from standard treatments like antipsychotics and benzodiazepines. Most current options focus on calming symptoms, but Rivastigmine works by enhancing communication between nerve cells in the brain, potentially addressing the root cause of delirium. Researchers are excited about Rivastigmine because it offers a possibility for more rapid symptom control and may reduce the need for sedative medications, which often come with side effects. This approach could lead to better outcomes for patients experiencing delirium, which is a common and challenging condition in hospitals.
What evidence suggests that rivastigmine might be an effective treatment for antimuscarinic delirium?
Research has shown that rivastigmine, a type of medication, can improve thinking and reduce restlessness in people with mild to moderate Alzheimer’s disease. This suggests potential benefits for antimuscarinic delirium (AMD), a condition marked by confusion and agitation. Some small studies and reports have indicated that rivastigmine could alleviate AMD symptoms. In this trial, participants in the rivastigmine arm will receive rivastigmine to assess its effectiveness for ongoing delirium or agitation. Although it hasn't been directly compared to the usual treatment, physostigmine, rivastigmine's ability to enhance cognition and calm agitation makes it a promising option for treating AMD.56789
Who Is on the Research Team?
Kevin Baumgartner, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals experiencing antimuscarinic delirium, a type of confusion and agitation due to certain medication or chemical poisoning. Details on who can join are not provided, but typically participants must meet specific health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rivastigmine or placebo for antimuscarinic delirium, with doses administered as needed for ongoing delirium or agitation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of agitation and delirium
What Are the Treatments Tested in This Trial?
Interventions
- Rivastigmine
Rivastigmine is already approved in European Union, United States for the following indications:
- Alzheimer's Disease
- Parkinson's Disease Dementia
- Alzheimer's Disease
- Parkinson's Disease Dementia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
American Academy of Clinical Toxicology
Collaborator
American Academy of Clinical Toxicology
Collaborator