Accelerating and optimising recruitment for dementia clinical trials – lessons learned from novel strategies employed in the STAND trial
Creators: name: Albertyn, Christopher P
name: Johar, Iskandar
name: Creese, Byron
name: Da Silva, Miguel Vasconcelos
name: Ta-Wei Guu
name: Kandangwa, Pooja
name: Simrat Kaur
name: Cornwall, Andrew
name: Aarsland, Dag
Publisher: name: F1000 Research Limited
Year: 2024

description: <b>Introduction &amp; Background</b><br>
Translational success for therapeutics targeting dementia falls far short of comparable other disease categories. This is partly due to the highly complex aetiological pathophysiology of the dementia's and associated neuropsychiatric symptoms, making the discovery of disease/symptom-modifying drug targets very challenging. However it is also partly due to very poor recruitment &amp; retention, with dementia clinical trials reported to take approximately twice as long as cardiovascular, psychiatry, neurology or oncology trials. This has significant financial repercussions for investors and drug developers, potentially dissuading the level of investment dementia therapeutics deserve! Given these historical recruitment difficulties, we developed a novel recruitment strategy as part of the Alzheimer’s Research UK ‘Sativex® for the Treatment of Agitation in Dementia’ (STAND) trial (ISRCTN #: 97163562).<br>
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<b>Materials &amp; Methods</b><br>
STAND explored a cannabinoid-based oral spray, Sativex®, for the treatment of agitation in UK nursing home residents living with Alzheimer’s Disease. STAND was a double-blind, placebo-controlled, feasibility trial aiming to recruit 60 participants in 12 months (target recruitment rate (RR) of 5 per month). Trial recruitment started in September 2021 and finished June 2022. With PPI, clinical and academic partners, we co-designed an innovative, systematic and dynamic strategy to optimise and accelerate recruitment to the STAND trial. We employed an iterative stakeholder mapping and engagement strategy and bespoke consenting protocol to optimise patient recruitment and screening success. We identified over 20 recruitment channels for potential participants, and executed dynamic engagement plans to target each one to achieve maximum efficiency.<br>
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<b>Results &amp; Conclusions</b><br>
We recruited 29 participants, falling short of our target of 60. Unfortunately, we were adversely impacted by nursing home COVID-19 restrictions during the BA.1/BA.2 omicron-variant wave December 2021 ~ April 2022. Also, as our trial start was delayed from May 2020 to September 2021, our drug supply expired twice during recruitment, shortening our total recruitment period to 10 months, and freezing recruitment for ~6 weeks during a re-supply. However, during May – June 2022, we achieved a very successful RR, doubling our predicted target RR in May, and tripling it in June. Moreover, despite the final recruited sample size, we argue that our novel recruitment strategy was highly effective and could be adopted by future dementia clinical trials to optimise recruitment.<br>
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<b>Further information</b><br>
This poster was presented at the Dementia's Platform UK Translation conference in March 2023. A more updated and in-depth description of the methodology &amp; analysis will be provided in a future paper submission.