Could Temperamental Features Modulate Participation in Clinical Trials?
Simona CintoliCamilla ElefanteClaudia RadicchiGiulio Emilio BrancatiSilvia BacciardiJoyce BonaccorsiGabriele SicilianoIcro MaremmaniGiulio PerugiGloria TognoniPublished in: Journal of clinical medicine (2023)
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.
Keyphrases
- mild cognitive impairment
- clinical trial
- cognitive decline
- phase iii
- phase ii
- study protocol
- physical activity
- open label
- healthcare
- bipolar disorder
- end stage renal disease
- randomized controlled trial
- chronic kidney disease
- gene expression
- dna methylation
- sleep quality
- placebo controlled
- stress induced
- quality improvement
- patient reported