rivastigmine transdermal / Generic mfg. - LARVOL DELTA

Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Zodiac Produtos Farmaceuticos S.A.

New P1 trial

Development of online monitoring strategy for continuous coating process of transdermal patches based on near-infrared spectroscopy. (PubMed, Int J Pharm) - "To address the challenges of quality control in continuous manufacturing, we developed a comprehensive near-infrared (NIR) spectroscopy-based monitoring strategy using rivastigmine patches as a model...When integrated into a continuous coating line, online models delivered highly accurate dry adhesive weight prediction (R2 = 0.998, RPD = 12.29) and reliable drug content monitoring (R2 = 0.948, RPD = 3.10) despite process variations in web speed and coating thickness. To the best of our knowledge, this work demonstrates the first integrated real-time NIR monitoring approach throughout the coating process, providing a practical PAT solution that significantly enhances process understanding and quality assurance in continuous production."

Journal

Evaluation of Artificial Intelligence-Based Rivastigmine on Gait Improvement in Patients with Cognitive Impairment and Correlation Analysis (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: Hangzhou Normal University Affiliated Hospital; Hangzhou Normal University Affiliated Hospital

New trial • CNS Disorders • Cognitive Disorders • Developmental Disorders

Treatment persistence with acetylcholinesterase inhibitors in Alzheimer's disease: Real-world evidence from a retrospective cohort study. (PubMed, J Alzheimers Dis) - "BackgroundAlzheimer's disease (AD) is the leading cause of dementia worldwide, yet long-term persistence with acetylcholinesterase inhibitors remains suboptimal in routine practice.ObjectiveTo compare real-world treatment persistence among patients with mild to moderate AD receiving oral donepezil, rivastigmine capsules, or transdermal rivastigmine patches, and to identify factors influencing discontinuation.MethodsIn this retrospective cohort study, 1062 patients aged ≥65 years with newly diagnosed AD were identified from a hospital registry between 2015 and 2019 and followed through 2021...Higher baseline CASI scores, younger age, and milder cognitive impairment predicted greater persistence, whereas adverse events markedly increased discontinuation.ConclusionsDonepezil demonstrated superior real-world persistence compared with rivastigmine. Structured dementia care programs substantially enhanced treatment continuity, underscoring the importance of both..."

HEOR • Journal • Real-world evidence • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Biomarkers. (PubMed, Alzheimers Dement) - "Rivastigmine treatment induced FC changes in frontal and occipito-cerebellar areas in patients with prodromal to mild AD that were associated with long-term memory performance improvements over 12 weeks. These rivastigmine-induced effects on resting-state brain activity and the mediating role of the α4β2 nicotinic receptor for acetylcholine are in line with previous findings. Neurotransmitter-related FC can be an MRI biomarker sensitive to test mechanisms of actions and to track neuroplastic changes induced by pharmacological treatments targeting specific neurotransmitter systems in people with AD."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders

Efficacy and safety of a novel, extended-release rivastigmine transdermal patch (TW-4752N) in patients with Alzheimer's disease: A 24-week randomized, double-blind trial with a 28-week open-label extension. (PubMed, J Alzheimers Dis) - "However, analysis of the per-protocol set demonstrated a significant intergroup difference in favor of TW likely suggesting a greater treatment effect with TW than with RT (p = 0.032). Adverse events (AEs) reported in ≥3% of patients were similar between the groups, with the only AE with an intergroup difference of ≥10% in incidence being application site pruritus (TW/RT, 27.6%/17.1%).ConclusionsTW represents a viable alternative option of interest to patients with AD, providing comparable or potentially greater efficacy than RT and comparable safety, as well as greater convenience of use."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Dermatology • Pruritus

TOO MUCH AT ONCE: QUETIAPINE OVERDOSE LEADING TO PRIAPISM (CHEST 2025) - "Due to encephalopathy and hypotension resistant to multiple fluid boluses, patient was admitted to ICU and started on phenylephrine, with physostigmine injections as needed and rivastigmine patch. This case shows the necessity for prompt response with coordination of care of quetiapine overdose since it can have multisystem effects. Accompanied by the rarer effect of ischemic priapism, sequelae can include erectile dysfunction due to tissue necrosis leading to fibrosis, urination issues, and decreased quality of life. Through quick management with active monitoring, clinicians can mitigate these anticholinergic effects in patients with an optimal return to baseline."

Cardiovascular • CNS Disorders • Depression • Epilepsy • Erectile Dysfunction • Fibrosis • Hypotension • Immunology • Psychiatry

Tolerability of rivastigmine transdermal patch in patients with Alzheimer's disease: a narrative review. (PubMed, Expert Opin Drug Saf) - "Tolerability of the patch improves over time, including at the highest dose level. Overall, the available evidence supports transdermal rivastigmine being generally well tolerated at doses up to 13.3 mg/24 h in patients with AD."

Clinical • Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia

Patching Up the Confusion: Rare Use of Rivastigmine Patch for Oxybutynin Overdose in a Pediatric Patient (AAP-NCE 2025) - "This is one of few reported cases demonstrating effective use of transdermal rivastigmine to manage anticholinergic poisoning in a pediatric patient. Transdermal rivastigmine patch should be explored as an option for reversal of anticholinergic toxicity in pediatric patients, especially those where oral administration is not feasible and where physostigmine is unavailable."

Clinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease • Pediatrics • Psychiatry • Urinary Incontinence • Urology

CHIEF PD: CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) (clinicaltrials.gov) - P3 | N=600 | Completed | Sponsor: University of Bristol | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Jul 2025

Trial completion • Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Recurrent Cholinergic Crisis Caused by Therapeutic-Dose Rivastigmine Patch in an Elderly Patient With Alzheimer's Disease: A Case Report. (PubMed, Cureus) - "After the third episode, rivastigmine was permanently discontinued, resulting in the complete resolution of both acute and chronic mild gastrointestinal and autonomic symptoms. This case highlights the diagnostic challenges of cholinergic crisis in elderly patients receiving ChEIs and underscores the importance of considering this condition when unexplained gastrointestinal or autonomic symptoms occur even during standard therapeutic dosing."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Gastroenterology • Gastrointestinal Disorder

An overview of the rivastigmine 13.3 mg/24h transdermal patch as a treatment option for Alzheimer's disease. (PubMed, Expert Rev Neurother) - "The high-dose 13.3 mg/24 h patch might offer benefits for some patients compared to the lower dose patch (4.6 mg/24 h) in patients with mild-to-moderate or severe AD, showing improvements in daily functioning and global clinical status on top of the cognitive benefits. The ability to titrate up to a dose of 13.3 mg/24 h provides an option for patients with severe AD or with an inadequate response to lower doses of rivastigmine."

Clinical • Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Transdermal rivastigmine as a therapeutic option in severe diphenhydramine-induced anticholinergic toxicity: A case report and literature review. (PubMed, Pharmacotherapy) - "We present the case of a 21-year-old female with confirmed diphenhydramine overdose (3600 mg) who demonstrated rapid clinical improvement after administration of a 9.5 mg/24-h rivastigmine transdermal patch. This case supports growing evidence suggesting that rivastigmine may serve as a safe and effective alternative when physostigmine is not accessible."

Journal • Cardiovascular • CNS Disorders

Rivastigmine as an alternative treatment for anticholinergic toxidrome in light of the physostigmine shortage: A case series. (PubMed, Am J Emerg Med) - "Our study shows that rivastigmine is a reasonable alternative to physostigmine based on the lack of adverse events reported and symptom relief."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Mood Disorders • Movement Disorders • Parkinson's Disease

Clinicians' Perspectives of Twice-Weekly Rivastigmine Patches for Alzheimer's Disease Treatment in Spain: The VIITAL 2S Study. (PubMed, Patient Prefer Adherence) - "Both specialists manifested preferring twice-weekly rivastigmine patches over daily ones, especially to increase caregivers' comfort, for patients without full-week caregiver support, and in cases of poor compliance with previous treatments. Neurologists and geriatricians consider the twice-weekly rivastigmine patch formulation beneficial for AD treatment in terms of treatment compliance, skin tolerability, satisfaction and comfort for patients and caregivers."

Journal • Alzheimer's Disease • CNS Disorders

Skin Lesions as Signs of Neuroenhancement in Sport. (PubMed, Brain Sci) - "Although specific neuroenhancement methods demonstrate distinctive dermatological side effects that might signal neurodoping, the current lack of robust clinical data involving athletes limits the ability to draw definitive conclusions. Athletes who engage in neurodoping without medical supervision are at an elevated risk of adverse dermatological and systemic reactions. Skin lesions, therefore, could represent a valuable early diagnostic marker for the inappropriate use or overuse of cognitive-enhancing drugs or neuromodulation therapies. The findings emphasize the need for focused clinical research to establish validated dermatological criteria for detecting neurodoping. This research could contribute significantly to the ongoing neuroethical discourse regarding the legitimacy and safety of cognitive enhancement in sports."

Journal • Review • Dermatology • Thermal Injury

Real-world assessment of caregiver preference and compliance to treatment with twice-weekly versus daily rivastigmine patches in Alzheimer's disease. (PubMed, J Alzheimers Dis) - "The twice-weekly rivastigmine patch offers a convenient and straightforward dosing regimen for caregivers, with potential to enhance adherence with treatment in AD patients without causing serious adverse events."

Compliance • Journal • Real-world • Real-world evidence • Alzheimer's Disease • CNS Disorders

Cost-Effectiveness Analysis of the Correct vs Improper Use of Rivastigmine Transdermal Patch in Patients With Alzheimer's Disease in Colombia (ISPOR-EU 2024) - "Proper titration and administration of the 13.3 mg/day Exelon patch is cost-effective for treating AD patients, resulting in significant health benefits and cost savings. Improper use leads to substantial additional costs and reduced effectiveness, emphasizing the importance of correct patch usage."

Clinical • Cost effectiveness • HEOR • Alzheimer's Disease • CNS Disorders

Severity of depressive symptoms at baseline predicts the six-month outcome of cholinesterase inhibitors on cognition in mild Alzheimer's Disease (ECNP 2024) - "With this pilot study, we intended to explore whether depressive symptomatology could be involved not only in pathogenic processes of dementia, but also in its cognitive response to treatments of choice such as ChEIs.Aims of the studyThe aims of the study were: (1) to evaluate the response to six-month ChEIs treatment (donepezil 10 mg/die or rivastigmine patch 9.5 mg/die) with psychometric tests measuring general cognitive performance, executive functions, and depressive symptoms in mild AD; (2) to verify whether the severity of depression at baseline could predict the cognitive response to six months of ChEIs treatment in mild AD...Addressing non-cognitive symptoms of dementia may be a critical strategy for maximizing the outcome of treatment, as common underlying pathophysiological processes could be involved in the overall response to therapy. Future studies should promote such global perspective in the management of cognitive impairment."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

CHIEF PD: CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: University of Bristol | Trial completion date: Apr 2024 ➔ Feb 2025 | Trial primary completion date: Apr 2023 ➔ May 2024

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Toward a Computationally-Informed, Personalized Treatment for Hallucinations (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Yale University | Trial completion date: Aug 2024 ➔ Aug 2032 | Trial primary completion date: Aug 2024 ➔ Aug 2032

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry

Rivastigmine for the management of anticholinergic delirium. (PubMed, Clin Toxicol (Phila)) - "In this case series, rivastigmine transdermal patch appeared to be less effective than oral rivastigmine capsules, likely due to its slow onset of action and/or insufficient dose. Rivastigmine can be used to treat anticholinergic delirium. In our case series oral rivastigmine appeared more effective than transdermal rivastigmine."

Journal • Anesthesia • Cardiovascular • CNS Disorders • Epilepsy • Gastrointestinal Disorder

Rivastigmine Bioequivalence Trial With Multiple Applications of Transdermal Patches (9.5 mg/24 h) (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: SocraTec R&D GmbH | Active, not recruiting ➔ Completed

Trial completion

Dual engine-driven bionic microneedles for early intervention and prolonged treatment of Alzheimer's disease. (PubMed, J Control Release) - "Specifically, free rivastigmine (RVT) and RVT particles were co-loaded within the MNs to construct the valve and chambers of the guava, respectively, which can serve as an active engine to promote drug permeation by generating capillary force...Pharmacodynamic studies further confirmed that the dual engine-driven bionic MNs were most effective in restoring memory and recognition functions in mice with short-term memory dysfunction. Therefore, the dual engine-driven bionic MNs hold great promise for highly efficient AD treatment."

Journal • Alzheimer's Disease • CNS Disorders

Transdermal Therapeutic Systems for the Treatment of Alzheimer's Disease: A Patent Review. (PubMed, CNS Neurol Disord Drug Targets) - "TTSs are primarily effective for delivering small molecules. The use of absorption enhancers and irritation mitigators can be necessary to enhance the performance. The development of these technologies is essential for the convenience of patients and caregivers."

Journal • Review • Alzheimer's Disease • CNS Disorders