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2 results

  • 11 - Phase 1 Trials in Alzheimer’s Disease Drug Development

  • from Section 3 - Alzheimer’s Disease Clinical Trials
  • Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
  • Book:
    Alzheimer's Disease Drug Development
    Published online:
    03 March 2022
    Print publication:
    31 March 2022, pp 135-149

  • Summary

    Phase 1 clinical trials are the entrance to the further clinical development of new compounds. The chapter describes the regulatory background and highlights most important issues about selection of the maximum recommended starting dose, dose escalation steps, and definition of maximum tolerated dose, or maximum applied dose in a study considering actual guidelines. There is an overview about selection of subject populations and frequently used trial designs. The principles of single-ascending-dose and multiple-ascending-dose tolerance studies are described with a few examples of studies in Alzheimer’s disease (AD). The safety assessment is important in clinical practice, as AD drugs will be used over many years, so excellent tolerability is a must! In Phase 1, a careful assessment of pharmacokinetic (PK) properties of a new compound forms the basis for dose selection in Phase 2 and 3 studies and supports the decision on the treatment regimen. The importance of inclusion of different biomarkers in these studies to allow assessment of pharmacodynamic and PK relationship and to potentially identify first signals in human studies indicating therapeutic usefulness in the indication.

  • Safety of psychotropic medications in people with COVID-19

  • G. Ostuzzi, D. Papola, C. Gastaldon, C. Barbui
  • Journal:
    European Psychiatry / Volume 64 / Issue S1 / April 2021
    Published online by Cambridge University Press:
    13 August 2021, p. S93
    • Article
      • You have access
      • Open access
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  • Introduction

    People with coronavirus disease (COVID-19) may frequently require treatment with psychotropic medications, but the underlying medical condition and possible interaction with medical treatments might pose serious safety issues.

    Objectives

    To review the direct and indirect evidence on the safety of psychotropic drugs in people with COVID-19 and provide practical recommendations for frontline clinicians.

    Methods

    An international, multi-disciplinary working group was established with the aim of producing evidence-based recommendations on the management of psychotropic medications in people with COVID-19, following the WHO Rapid Advice Guidelines methodology in the context of a public health emergency. Evidence retrieved was focused on the risk of respiratory, cardiovascular, infective, hemostatic, and consciousness alterations related to the use of psychotropic medications. Furthermore, drug-drug interactions between psychotropic and medical treatments used in people with COVID-19 was reviewed and critically discussed by the working group.

    Results

    The analysis of available evidence, although indirect, showed that all classes of psychotropic medications might carry relevant safety risks for people with COVID-19. The working group produced a set of 12 recommendations to support clinicians in the assessment of the anticipated risk of psychotropic-related unfavourable events, and how to practically manage this risk, including when it is appropriate to avoid, withdraw, switch, or adjust the dose of the medication.

    Conclusions

    The present evidence-based recommendations will improve the quality of psychiatric care in people with COVID-19, allowing an appropriate management of the medical condition without worsening the psychiatric condition and vice versa.

    Disclosure

    No significant relationships.