Phase 4 Rivastigmine Trial, Clozapine Poisoning, 100 Patients
Summary
A Phase 4 clinical trial (NCT07545382) evaluating rivastigmine for treating anticholinergic delirium and CNS depression has been registered, enrolling 100 patients at the Poison Control Center of Alexandria University Main Hospital. The study focuses on patients with clozapine toxicity, representing 90% of the cohort, and also investigates reversal of TCA-induced CNS depression using cholinesterase inhibitors. Rivastigmine effectiveness in restoring consciousness and cognitive function will be assessed as the primary outcome.
“This study aims to evaluate the clinical efficacy of rivastigmine in reversing the full spectrum of toxic anticholinergic delirium, with a specific focus on hypoactive delirium and CNS depression.”
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This document registers a Phase 4 clinical trial (NCT07545382) investigating rivastigmine as a treatment for anticholinergic delirium and CNS depression. The trial will enroll 100 patients at Alexandria University Main Hospital's Poison Control Center, with 90% presenting clozapine toxicity. Secondary objectives include evaluating rivastigmine safety and efficacy for TCA-induced CNS depression, challenging traditional concerns about cholinesterase inhibitor use in such cases. For pharmaceutical companies and clinical investigators, this trial represents an investigation into an off-label use of rivastigmine (FDA-approved for Alzheimer's disease and Parkinson's disease dementia) for toxicological indications.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Rivastigmine for the Treatment of Hypoactive Anticholinergic Delirium and CNS Depression Associated Mainly With Clozapine Poisoning.
Phase 4 NCT07545382 Kind: PHASE4 Apr 22, 2026
Abstract
This study aims to evaluate the clinical efficacy of rivastigmine in reversing the full spectrum of toxic anticholinergic delirium, with a specific focus on hypoactive delirium and CNS depression. These presentations were predominantly associated with clozapine toxicity, accounting for 90% of the study population. Additionally, the research investigates the safety and efficacy of rivastigmine in reversing CNS depression caused by Tricyclic Antidepressants (TCAs), challenging traditional concerns regarding the use of cholinesterase inhibitors in such cases.
The study was conducted on 100 patients at the Poison Control Center of Alexandria University Main Hospital. The primary objective is to assess the effectiveness of rivastigmine in restoring consciousness and improving cognitive function in patients presenting with delirium and depressed mental status.
Conditions: Anticholinergic Delirium, Clozapine Poisoning, Antipsychotic Toxicity, CNS Depression, Hypoactive Delirium, Tricyclic Antidepressant Poisoning, Procyclidine Induced Delirium
Interventions: Rivastigmine
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