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Ongoing Research Protocols for the Pharmacological Treatment of Neuropsychiatric Symptoms in Dementia

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  • Neurosciences of Frailty
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Abstract

The implementation of effective interventions for neuropsychiatric symptoms (NPS) is perceived as one of the most pressing research priorities in the field of dementia and one of the main unmet needs from the perspective of affected individuals and their caregivers and relatives. Nevertheless, to date, only a relatively marginal part of dementia research has focused on NPS. This study aimed to describe and discuss the state of the art concerning the identification and development of new pharmacological treatments for NPS in dementia. A review of 320 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials enrolling patients with dementia were selected. Only studies adopting clinical measures of NPS frequency and/or severity as primary outcome were retained and analyzed. Overall, only a minority of ongoing phase 1, 2, 3 and 4 protocols on dementia (i.e., 9.0%) is primarily targeting NPS. Most of these studies are adopting a placebo-controlled parallel assignment design, testing oral compounds, and targeting specific NPS (mostly agitation and/or aggression). A total of 3,445 subjects with dementia will tentatively be recruited in these trials. The methodologies adopted in these studies, the characteristics of the tested interventions, the eligibility criteria, and the operational definitions of NPS are presented and discussed. The relevance of NPS is not yet matched by an adequate research effort. The current tendency at privileging disease-modifying approaches and other symptoms of dementia and the methodological complexity of studying NPS are still substantially contributing to the gap between research activities and clinical needs.

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Author notes

  1. These Authors have equally contributed to the present study.

Authors and Affiliations

  1. Department of Human Neuroscience, “Sapienza” University of Rome, Viale dell’Università 30, 00185, Rome, Italy

    Marco Canevelli, G. Remoli, M. Toccaceli Blasi, L. Tariciotti, G. Sarli, M. Valletta, F. D’Antonio & G. Bruno

  2. National Center for Disease Prevention and Health Promotion, National Institute of Health, Rome, Italy

    Marco Canevelli & N. Vanacore

  3. Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy

    M. Cesari

  4. Geriatric Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

    M. Cesari

Authors
  1. Marco Canevelli
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  2. G. Remoli
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  3. M. Toccaceli Blasi
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  4. L. Tariciotti
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  5. G. Sarli
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  6. M. Valletta
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  7. F. D’Antonio
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  8. N. Vanacore
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  9. M. Cesari
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  10. G. Bruno
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Corresponding author

Correspondence to Marco Canevelli.

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Ethical standards: None declared by the Authors.

Additional information

Conflicts of interest disclosure: Authors have no competing interest to disclose for the present study. Marco Canevelli is supported by a research grant of the Italian Ministry of Health (GR-2016-02364975) for the project “Dementia in immigrants and ethnic minorities living in Italy: clinical-epidemiological aspects and public health perspectives” (ImmiDem). Matteo Cesari has received honoraria for presentations at scientific meetings and/or research funding from Nestlé and Pfizer. He is involved in the coordination of an Innovative Medicines Initiative-funded project (including partners from the European Federation Pharmaceutical Industries and Associates [Sanofi, Novartis, Servier, GSK, Lilly]).

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Canevelli, M., Remoli, G., Toccaceli Blasi, M. et al. Ongoing Research Protocols for the Pharmacological Treatment of Neuropsychiatric Symptoms in Dementia. J Frailty Aging 10, 22–30 (2021). https://doi.org/10.14283/jfa.2020.36

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  • DOI: https://doi.org/10.14283/jfa.2020.36

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