Patient and caregiver views on participating in clinical trials for behavior problems with Alzheimer’s disease

Abstract

AbstractBackgroundAlong with memory problems and functional impairment, people with Alzheimer’s dementia often suffer from behavioural and psychological symptoms of dementia (BPSD), such as hallucinations, delusions, anxiety and agitation. Current used medications have modest benefits and significant side effects. Promising evidence suggests that cannabidiol (CBD) a non‐psychoactive and non‐addictive substance present in the cannabis plant extract may be useful in treating these symptoms. We conducted a randomised, double‐blind, placebo‐controlled trial of CBD for AD patients with BPSD. However, it is also important to seek to explore the views of potential participants through qualitative research methods about their acceptance of such interventions and participating in such trials especially during the COVID‐19 pandemic period.MethodsAD patients with BPSD were recruited within a single site, South London and Maudsley NHS trust, UK. We carried out semi structured quality interview for participants and their carers who were randomised and received treatment within the feasibility trial. The purpose of the qualitative interviews was to explore participants’ experiences of taking part in the trial including what encouraged them to take part, their views on the intervention and how they are finding the trial in general.ResultsBoth AD participants (n = 15) and their carers (14) were interviewed. Only five AD participants could reasonably participate due to their symptoms. All the carers completed the interview. The key motivator for participating in the trial identified was to derive health benefits from the intervention (100% carers), and 43% also had altruistic motivation to help other people and research. Of the 5 AD patients, 4 had altruistic motivation and one said for health benefits. There were no concerns taking CBD orally in little capsule form. All the participants expressed positive experience with adequate information, thorough and flexible assessments (face to face and virtual), being visited at home or taxis arranged for hospital visits.ConclusionsThe findings demonstrate good acceptability and compliance for CBD among elderly with AD and BPSD. Health benefit was the key motivator for enrolling in the clinical trial facilitated by appropriate arrangements for participation. Learnings from this study would help plan further trials for this cohort.