Barriers and Facilitators to Participation in Clinical Trials Related to Familial Frontotemporal Dementia: A Qualitative Study.

Aims: Familial frontotemporal dementia (fFTD) is an inherited neurodegenerative condition characterised by executive dysfunction, impairments in social cognition, behaviour and language. Although no disease-modifying interventions are currently available, several treatments are undergoing clinical trials. This study sought to understand the barriers and facilitators to taking part in such trials, as well as general perceptions of the treatments undergoing trial.

Method: Twelve interviews took place with fourteen participants: eight individuals who were genetically at-risk of developing fFTD, two individuals diagnosed with fFTD and four spousal carers. Their views and experiences of clinical trials were explored using thematic analysis.

Results: Five main themes were developed: (1) effects on the individual, (2) implications for others, (3) systemic considerations, (4) the impact of genetic status and disease progression and (5) the role of communication and understanding.

Conclusions: The decision to participate in clinical trials was said to be complex, involving consideration of logistical barriers alongside health implications. Participants identified potential advantages of participating in clinical trials to be direct health benefits and the ability to help others, however risks to participants and their families' physical and psychological wellbeing were also named. Relationships between organisations and participants were consistently considered to be important, with lack of psychological care at various timepoints post diagnosis; unclear communication and expectation-setting; and inadequate organisational collaboration all identified as barriers. Participants indicated that increased health-professional interest in FTD and an associated increase in opportunities would be key facilitators for greater participation in clinical trials.