Cannabidiol for neuropsychiatric symptoms in Alzheimer’s dementia

Abstract Background Behavioural and Psychological Symptoms of Dementia (BPSD) in people with Alzheimer’s disease (AD) is particularly distressing to patients and carers. There are currently no licensed medications for BPSD, and the current available treatments have limited benefits and greater risk for side effects. There is therefore a considerable unmet clinical need for interventions that are safe, well‐tolerated and effective for treating BPSD in AD. Cannabidiol (CBD), a non‐addictive substance present in cannabis shows promise for treating psychotic and anxiety symptoms in people without dementia and is generally safe and well‐tolerated in elderly. However, its efficacy, safety and tolerability need to be systematically tested in elderly with dementia. We aimed to evaluate acceptability and tolerability of CBD as treatment for BPSD in patients with AD. Methods We are conducting a double‐blind, parallel group, placebo‐controlled pragmatic randomized controlled feasibility trial (EudraCT Number ‐ 2019‐002106‐52) and recruiting AD patients with BPSD within Mental Health for Older Adults services, South London and Maudsley NHS trust, United Kingdom. Half of the participants receive 600 mg of CBD orally once a day over 6 weeks and the other half receive a placebo, in addition to their usual treatment for 6 weeks. Clinical data collected includes measures of cognition, Clinical Dementia Rating for staging, behaviour symptoms on Neuropsychiatric Inventory (NPI), global functioning, Quality of Life for patients and carer’s burden. Tolerability is assessed by self‐report of side‐effects, and side‐effect rating scale. Results Of the participants recruited and randomised so far, there have been no withdrawals or serious adverse events. The study is ongoing and due for completion at the end of April 2022, following which we will have the data to analyse and present the findings at the July 2022 conference. Conclusions CBD has been generally acceptable and safe for people with AD with BPSD. The final analysis and findings related to adverse events, and changes in clinical measures for the groups (CBD treatment versus placebo) including BPSD, cognition etc. will be presented at the conference.