42 Participants Needed

Rivastigmine for Delirium

(RIVA-AP Trial)

KB
Overseen ByKevin Baumgartner, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
Must be taking: Physostigmine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine is effective in reversing AMD but has a short duration of action, and patient commonly experience recurrence of AMD after initial control with physostigmine. Recent case reports and small observational studies suggest that rivastigmine, which has a longer duration of action than physostigmine, might be useful in the treatment of AMD. In order to investigate the effectiveness of rivastigmine in preventing recurrence of AMD after initial control with physostigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine after initial control of AMD with physostigmine will experience less recurrence of antimuscarinic delirium than those treated with placebo.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Rivastigmine for treating delirium?

Rivastigmine has been shown to improve cognitive function in patients with Alzheimer's disease, which suggests it may help with similar symptoms in delirium, as both conditions involve cognitive impairment.12345

How is the drug rivastigmine unique for treating delirium?

Rivastigmine is unique because it is available as a transdermal patch, which allows for smooth and continuous drug delivery, potentially increasing treatment compliance and reducing side effects compared to oral medications.13678

Research Team

KB

Kevin Baumgartner, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I am 10 years old or older.
I have been diagnosed with delirium caused by antimuscarinic drugs.
My confusion from antimuscarinic delirium is under control after treatment.
See 1 more

Exclusion Criteria

I cannot safely take pills, as determined by my doctor.
I am at high risk for serious heart or brain problems from antimuscarinic poisoning.
I am at high risk for side effects from AChE inhibitors.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either rivastigmine or placebo to prevent recurrence of antimuscarinic delirium after initial control with physostigmine

8-36 hours
Continuous monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Rivastigmine
Trial Overview 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.
Participant Groups
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.

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

🇪🇺
Approved in European Union as Exelon for:
  • Alzheimer's Disease
  • Parkinson's Disease Dementia
🇺🇸
Approved in United States as Exelon for:
  • Alzheimer's Disease
  • Parkinson's Disease Dementia

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+

Findings from Research

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]
Rivastigmine tartrate is effective in improving or maintaining cognitive function, daily living activities, and behavior in patients with mild to moderate Alzheimer's disease, based on clinical trials lasting up to 52 weeks.
The most common side effects are mild to moderate gastrointestinal issues, and treatment may lead to cost savings in care, particularly by delaying the need for institutionalization, especially in patients with moderate Alzheimer's disease.
A review of rivastigmine: a reversible cholinesterase inhibitor.Williams, BR., Nazarians, A., Gill, MA.[2022]

References

A 52-week study of the efficacy of rivastigmine in patients with mild to moderately severe Alzheimer's disease. [2022]
Bioequivalence Study of Rivastigmine 6 mg Capsules (Single Dose) in Healthy Volunteers. [2018]
A review of rivastigmine: a reversible cholinesterase inhibitor. [2022]
Impact of rivastigmine patch and capsules on activities of daily living in Alzheimer's disease. [2015]
Long-term effectiveness of rivastigmine patch or capsule for mild-to-severe Alzheimer's disease: a meta-analysis. [2018]
Rivastigmine transdermal patch 13.3 mg/24 h: a review of its use in the management of mild to moderate Alzheimer's dementia. [2021]
Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects. [2022]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
A fatal outcome after unintentional overdosing of rivastigmine patches. [2019]
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