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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 belowSelect...
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 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
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 moreSide effects data
From 2022 Phase 4 trial • 100 Patients • NCT0298940210%
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
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