Could Temperamental Features Modulate Participation in Clinical Trials?

Author:

Cintoli Simona1,Elefante Camilla2ORCID,Radicchi Claudia3,Brancati Giulio Emilio2ORCID,Bacciardi Silvia45,Bonaccorsi Joyce1,Siciliano Gabriele16,Maremmani Icro278ORCID,Perugi Giulio27ORCID,Tognoni Gloria16

Affiliation:

1. Neurology Unit, Santa Chiara University Hospital, 56126 Pisa, Italy

2. Psychiatry Unit, Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy

3. Institute of Neuroscience, National Research Council, 56124 Pisa, Italy

4. Department of Psychiatry, North-Western Tuscany Region NHS Local Health Unit, Versilia Zone, 55049 Viareggio, Italy

5. PISA-School of Clinical and Experimental Psychiatry, 56100 Pisa, Italy

6. Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy

7. G. De Lisio Institute of Behavioral Sciences, 56127 Pisa, Italy

8. Saint Camillus International University of Health and Medical Sciences (UniCamillus), 00131 Rome, Italy

Abstract

The prodromal stages of Alzheimer’s disease (AD) are the primary focus of research aimed at slowing disease progression. This study explores the influence of affective temperament on the motivation of people with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) to participate in clinical trials. One hundred four subjects with MCI and SCD were screened for participation in pharmacological and non-pharmacological trials. Affective temperament was assessed based on the Temperament Evaluation of the Memphis, Pisa, Paris and San Diego (TEMPS) scale. Demographic variables and temperament subscales scores were compared between MCI and SCD patients and among patients participating in the pharmacological trial, the non-pharmacological trial and refusing participation. Twenty-one subjects consented to participate in the pharmacological trial, seventy consented to the non-pharmacological trial and thirteen refused to participate in any trial. Patients with SCD had greater education and more depressive temperamental traits than those with MCI. While older age, higher education and anxious temperament were negatively associated with participation in the pharmacological trial, irritable temperamental positively predicted pharmacological trial participation. In conclusion, temperamental features may affect the willingness of patients with MCI and SCD to take part in clinical trials and, especially, the choice to participate in pharmacological studies.

Publisher

MDPI AG

Subject

General Medicine

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