Rivastigmine for Delirium

(RIVA-AM Trial)

Not currently recruiting at 1 trial location
KB
Overseen ByKevin Baumgartner, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests rivastigmine to determine its effectiveness in treating antimuscarinic delirium, a type of confusion and agitation caused by certain poisons. Since the usual treatment, physostigmine, is difficult to obtain, researchers aim to assess whether rivastigmine can serve as a suitable alternative. Participants will receive either rivastigmine or a placebo (a pill with no active drug) to evaluate which better alleviates symptoms. This trial suits individuals diagnosed with antimuscarinic delirium who experience significant confusion and agitation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that rivastigmine is likely to be safe for humans?

Research has shown that rivastigmine is generally safe for use. In other studies, some patients taking rivastigmine experienced common side effects such as nausea, vomiting, and dizziness, which were usually mild. Rivastigmine has also been used in patients with Alzheimer's disease, providing insights into its safety. However, using rivastigmine for antimuscarinic delirium (AMD) remains under investigation, so more research is needed to fully understand its safety and effectiveness for this condition.12345

Why do researchers think this study treatment might be promising for delirium?

Rivastigmine is unique because it targets delirium through a mechanism that is different from standard treatments like antipsychotics and benzodiazepines. Most current options focus on calming symptoms, but Rivastigmine works by enhancing communication between nerve cells in the brain, potentially addressing the root cause of delirium. Researchers are excited about Rivastigmine because it offers a possibility for more rapid symptom control and may reduce the need for sedative medications, which often come with side effects. This approach could lead to better outcomes for patients experiencing delirium, which is a common and challenging condition in hospitals.

What evidence suggests that rivastigmine might be an effective treatment for antimuscarinic delirium?

Research has shown that rivastigmine, a type of medication, can improve thinking and reduce restlessness in people with mild to moderate Alzheimer’s disease. This suggests potential benefits for antimuscarinic delirium (AMD), a condition marked by confusion and agitation. Some small studies and reports have indicated that rivastigmine could alleviate AMD symptoms. In this trial, participants in the rivastigmine arm will receive rivastigmine to assess its effectiveness for ongoing delirium or agitation. Although it hasn't been directly compared to the usual treatment, physostigmine, rivastigmine's ability to enhance cognition and calm agitation makes it a promising option for treating AMD.56789

Who Is on the Research Team?

KB

Kevin Baumgartner, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Diagnosis of antimuscarinic delirium by history and physical examination, in the opinion of the treating attending toxicologist
I am at least 10 years old.
I am experiencing significant agitation and confusion that could improve with specific treatment.

Exclusion Criteria

I am under 10 years old.
Patient is pregnant or a ward of the state
Inability to safely tolerate oral medication, in the judgement of the treating attending physician
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive rivastigmine or placebo for antimuscarinic delirium, with doses administered as needed for ongoing delirium or agitation

8-36 hours
Continuous monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of agitation and delirium

1 week
Regular assessments every 2 hours until sustained recovery

What Are the Treatments Tested in This Trial?

Interventions

  • Rivastigmine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RivastigmineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Rivastigmine is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Exelon for:
🇺🇸
Approved in United States as Exelon for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

American Academy of Clinical Toxicology

Collaborator

Trials
3
Recruited
100+

American Academy of Clinical Toxicology

Collaborator

Trials
3
Recruited
100+

Published Research Related to This Trial

The study demonstrated that the new rivastigmine transdermal patch (RIV-TDS) is bioequivalent to the marketed Exelon patch, meaning they deliver the same amount of the drug into the bloodstream, which is important for consistent treatment of Alzheimer's disease.
RIV-TDS showed better skin adhesion and tolerability compared to the reference product, suggesting it may enhance patient compliance and comfort during treatment.
Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects.Morte, A., Vaqué, A., Iniesta, M., et al.[2022]
In a 52-week study involving patients with mild to moderately severe Alzheimer's disease, those treated with rivastigmine tartrate showed significantly better cognitive function compared to those who received a placebo.
The study included an initial 26-week double-blind phase followed by a 26-week open-label extension, demonstrating the sustained efficacy of rivastigmine over a full year.
A 52-week study of the efficacy of rivastigmine in patients with mild to moderately severe Alzheimer's disease.Farlow, M., Anand, R., Messina, J., et al.[2022]
A study involving 40 healthy men demonstrated that the generic formulation of rivastigmine is bioequivalent to the brand Exelon, with similar pharmacokinetic profiles as shown by comparable AUC and Cmax values.
Both the generic and reference formulations were well tolerated by participants, indicating that the generic version is a safe alternative to the brand-name drug.
Bioequivalence Study of Rivastigmine 6 mg Capsules (Single Dose) in Healthy Volunteers.Abhyankar, D., Shedage, A., Gole, M., et al.[2018]

Citations

EXACT: rivastigmine improves the high prevalence of ...A randomized trial evaluating the efficacy and safety of ENA 713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to ...
Rivastigmine for Delirium · Info for ParticipantsRivastigmine tartrate is effective in improving or maintaining cognitive function, daily living activities, and behavior in patients with mild to moderate ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/27111084/
Effects on agitation with rivastigmine patch monotherapy ...In this trial of mild to moderate AD patients, the rivastigmine patch monotherapy group experienced a reduction of non-aggressive agitated behaviors.
Rivastigmine Tartrate - Drug Targets, Indications, PatentsClinical Results associated with Rivastigmine Tartrate. Login to view more data. 100 Translational Medicine associated with Rivastigmine Tartrate. Login to ...
Rivastigmine transdermal patch: a review of its use in the ...Rivastigmine, a cholinesterase inhibitor, is available as a transdermal patch (Exelon[R] patch, Rivastach[R] patch, Prometax[R] patch) for the treatment of ...
Rivastigmine Use in the Treatment of Antimuscarinic DeliriumRivastigmine appears to be safe in this population. Larger studies are warranted to determine the optimal dosing, including route(s) of administration, and to ...
EXELON® PATCH (Rivastigmine Hydrogen Tartrate)Symptoms: Manifestations include nausea, vomiting, diarrhea, abdominal pain, dizziness,. Page 8. EXELON® PATCH (Rivastigmine Hydrogen Tartrate).
A 24-Week, Open-Label Extension Study to Investigate the ...the long-term safety of rivastigmine 13.3 mg/24 h patch in patients with severe AD. ... (rivastigmine tartrate) prescribing Information. 2013. Available at: http ...
Oscar Clinical Guideline: Rivastigmine (Exelon) (PG212, Ver. 2)○ Rivastigmine Tartrate Oral capsule. ○ Rivastigmine Transdermal Patch - 24 ... There are no high quality large clinical trials to support the safety and efficacy ...
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