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Cholinesterase Inhibitor

Rivastigmine for Delirium (RIVA-AP Trial)

Phase 2

Recruiting

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

Patients must be 10 years of age or older

Must not have

Evidence of significant risk for serious cardiac or neurologic sequelae of antimuscarinic poisoning

Evidence of significant risk of adverse effect of AChE-I

Timeline

Screening 3 weeks

Treatment Varies

Follow Up typically 8-36 hours after randomization

Summary

This trial aims to test if a drug called rivastigmine can prevent the recurrence of antimuscarinic delirium (AMD) after initial treatment with physostigmine. AMD is a

Who is the study for?

This trial is for patients who have experienced antimuscarinic delirium (AMD), a type of confusion and agitation caused by certain medications or poisons. Participants must have had their AMD initially controlled with physostigmine but are at risk of its recurrence.

What is being tested?

The study tests if rivastigmine, which lasts longer than physostigmine, can prevent the return of AMD symptoms after initial treatment. Patients will be randomly assigned to receive either rivastigmine or a placebo in this controlled trial.

What are the potential side effects?

Rivastigmine may cause side effects such as nausea, vomiting, diarrhea, loss of appetite, weight loss, dizziness or fainting when standing up too quickly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 10 years old or older.

Exclusion Criteria

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

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I am at high risk for serious heart or brain problems from antimuscarinic poisoning.

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I am at high risk for side effects from AChE inhibitors.

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I am allergic to rivastigmine or similar medications.

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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

Incidence of AMD recurrence

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 / 5Eligibility criteria met