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Cholinesterase Inhibitor

Rivastigmine for Delirium (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)

Must not have

Evidence of significant risk for serious cardiac or neurologic sequelae of antimuscarinic poisoning: Any known or suspected seizure activity prior to enrollment, QRS duration >100 milliseconds on EKG at enrollment, Any ventricular dysrhythmia prior to enrollment, Respiratory failure of any etiology requiring endotracheal intubation, Any hypotension at enrollment, Any administration of sodium bicarbonate, hypertonic saline, vasopressors, inotropes, antiarrhythmic agents, or intravenous lipid emulsion prior to enrollment, Unacceptable risk of serious medical sequelae of antimuscarinic poisoning in the judgment of the treating attending toxicologist, Evidence of significant risk of adverse effect of AChE-I: Bradycardia or risk of AChE-I induced bradycardia at enrollment, Known or suspected seizure disorder, History of asthma or COPD or wheezing during index presentation, Known or suspected physical obstruction of intestinal or urogenital tract, Known or suspected peptic ulcer disease, Any known allergy or intolerance to rivastigmine or other AChEI

Age less than 10 years at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up typically 8-36 hours after randomization

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 10 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ typically 8-36 hours after randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to control of agitation and delirium

Secondary study objectives

Bradycardia

Disposition

Duration of agitation and delirium

+8 more

Side effects data

From 2022 Phase 4 trial • 100 Patients • NCT02989402

10%

URINARY TRACT INFECTION

SKIN IRRITATION

VOMITING

DECREASED APPETITE

DEMENTIA

RESPIRATORY TRACT INFECTION

CEREBROSPINAL FLUID LEAKAGE

CEREBRAL HAEMORRHAGE

HYPONATRAEMIC SEIZURE

PNEUMONIA ASPIRATION

ARRHYTHMIA

100%

80%

60%

40%

20%

Study treatment Arm

Rivastigmine Patch

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

0 / 4Eligibility criteria met