Could a common Alzheimer's drug tame Poison-Induced delirium?
NCT ID NCT06382649
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether rivastigmine, a drug used for Alzheimer's, can quickly calm agitation and confusion caused by poisoning from medications that block certain nerve signals. About 42 people aged 10 and older with this type of delirium will receive either rivastigmine or a placebo. The goal is to see if rivastigmine helps resolve symptoms faster than supportive care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rivastigmine
- What this could lead to
- If it works, this could provide a widely available treatment for dangerous delirium caused by certain poisonings, especially when the standard antidote is scarce.
- What could go wrong
- This is a small early-phase trial with only 42 participants, so results may not apply broadly. Rivastigmine may not work better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 10 years of age or older * Diagnosis of antimuscarinic delirium by history and physical examination, in the opinion of the treating attending toxicologist. * Reasonably likely to benefit from antidotal therapy for antimuscarinic delirium, as demonstrated by clinically significant agitation and delirium: 1. Richmond Agitation-Sedation Scale (RASS) of +1 or higher at the time of enrollment 2. Positive for delirium as defined by the Confusion Assessment Method for the ICU (CAM-ICU) Exclusion Criteria: * Age less than 10 years at time of enrollment * Surrogate decision maker not available to provide informed consent for enrollment. * Patient is pregnant or a ward of the state. * Inability to safely tolerate oral medication, in the judgement of the treating attending physician. * Evidence of significant risk for serious cardiac or neurologic sequelae of antimuscarinic poisoning: a. Any known or suspected seizure activity prior to enrollment b. QRS duration \>100 milliseconds on EKG at enrollment c. Any ventricular dysrhythmia prior to enrollment d. Respiratory failure of any etiology requiring endotracheal intubation e. Any hypotension at enrollment: i. Adults: systolic blood pressure (SBP) \<90 mmHg ii. Children ≥10: systolic blood pressure (SBP) \<90 mmHg, as per Pediatric Advanced Life Support (PALS) age-based cutoff for children 10 years of age or older3 f. Any administration of sodium bicarbonate, hypertonic saline, vasopressors, inotropes, antiarrhythmic agents, or intravenous lipid emulsion prior to enrollment. g. Unacceptable risk of serious medical sequelae of antimuscarinic poisoning in the judgment of the treating attending toxicologist. * Evidence of significant risk of adverse effect of AChE-I: a.Bradycardia or risk of AChE-I induced bradycardia at enrollment: i. Adults: heart rate (HR) \<80 beats per minute ii. Children: heart rate below the median heart rate for age as proposed by Fleming et al.33: 1\. Ages 10-12: HR \<84 beats per minute 2. Ages 12-15: HR \<78 beats per minute 3. Ages 15-18: HR \<73 beats per minute b. Known or suspected seizure disorder. c. History of asthma or COPD or wheezing during index presentation d. Known or suspected physical obstruction of intestinal or urogenital tract i. Ileus and/or urinary retention due to antimuscarinic poisoning do not exclude patients from enrollment. e. Known or suspected peptic ulcer disease. * Any known allergy or intolerance to rivastigmine or other AChEI.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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