← Back to Search

Cholinesterase Inhibitor

Rivastigmine for Delirium (RIVA-AP 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
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
Awards & highlights

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
Select...
I am 10 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am at high risk for serious heart or brain problems from antimuscarinic poisoning.
Select...
I am at high risk for side effects from AChE inhibitors.
Select...
I am allergic to rivastigmine or similar medications.
Select...
I am under 10 years old.

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
Incidence of AMD recurrence
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%
SKIN IRRITATION
3%
VOMITING
3%
DECREASED APPETITE
1%
DEMENTIA
1%
RESPIRATORY TRACT INFECTION
1%
CEREBROSPINAL FLUID LEAKAGE
1%
CEREBRAL HAEMORRHAGE
1%
HYPONATRAEMIC SEIZURE
1%
PNEUMONIA ASPIRATION
1%
ARRHYTHMIA
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,516 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
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top