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Cholinesterase Inhibitor

Rivastigmine for Anticholinergic Toxicity (RIVA-AM Trial)

Phase 2
Waitlist Available
Led By Kevin Baumgartner, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
10 years of age or older
Reasonably likely to benefit from antidotal therapy for antimuscarinic delirium, as demonstrated by clinically significant agitation and delirium: Richmond Agitation-Sedation Scale (RASS) of +1 or higher at the time of enrollment, Positive for delirium as defined by the Confusion Assessment Method for the ICU (CAM-ICU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up typically 8-36 hours after randomization
Awards & highlights

RIVA-AM Trial Summary

"This trial aims to study a potential new treatment, rivastigmine, for a toxic condition called antimuscarinic delirium. The current standard treatment, physostigmine, is not

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if rivastigmine helps treat antimuscarinic delirium faster than a placebo. Participants will be randomly assigned to receive either rivastigmine or an inactive substance (placebo) in this controlled trial.See study design
What are the potential side effects?
While the side effects of rivastigmine aren't listed here, common ones may include nausea, vomiting, diarrhea, dizziness, and headache. The severity can vary from person to person.

RIVA-AM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 10 years old.
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I am experiencing significant agitation and confusion that could improve with specific treatment.

RIVA-AM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~typically 8-36 hours after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and typically 8-36 hours after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to control of agitation and delirium
Secondary outcome measures
Bradycardia
Disposition
Duration of agitation and delirium
+8 more

Side effects data

From 2022 Phase 4 trial • 100 Patients • NCT02989402
10%
URINARY TRACT INFECTION
3%
VOMITING
3%
DECREASED APPETITE
3%
SKIN IRRITATION
1%
PNEUMONIA ASPIRATION
1%
ARRHYTHMIA
1%
RESPIRATORY TRACT INFECTION
1%
CEREBRAL HAEMORRHAGE
1%
CEREBROSPINAL FLUID LEAKAGE
1%
DEMENTIA
1%
HYPONATRAEMIC SEIZURE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rivastigmine Patch

RIVA-AM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RivastigmineExperimental Treatment1 Intervention
Patients in the rivastigmine arm will receive rivastigmine 3mg by mouth once, followed by rivastigmine 1.5mg by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for up to three doses.
Group II: PlaceboPlacebo Group1 Intervention
Patients in the placebo arm will receive oral placebo by mouth once, followed by oral placebo every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for up to three doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivastigmine
2018
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,663 Total Patients Enrolled
American Academy of Clinical ToxicologyUNKNOWN
2 Previous Clinical Trials
61 Total Patients Enrolled
Kevin Baumgartner, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
42 Total Patients Enrolled
~28 spots leftby Jul 2026
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