Fastball

Background 55 million people globally are living with dementia, projected to rise to 78 million by 2030. Early diagnosis tools are desperately needed, with diagnosis typically occurring late in the disease process and misdiagnosis common due to the overlap of cognitive symptoms. Late and inaccurate diagnosis delays effective intervention and implementation of coordinated care plans, leading to poor symptom management, patient and carer distress and significant economic costs associated with extended provision of care. We have developed a new tool for earlier and more accurate diagnosis of dementia. Fastball is a novel, fast, passive biomarker of cognitive function, that uses cheap, scalable electroencephalography (EEG) technology. It is sensitive to early dementia, language, education, effort and anxiety independent and can be used in any setting including patients homes Aim We aim to improve the early detection of dementia by establishing Fastball as a new functional biomarker of cognitive impairment and provide a commercial platform for scale-up and implementation. Hypothesis We predict that Fastball will detect early Alzheimer s disease and discriminate it from non-Alzheimer s dementias earlier and more accurately than standardised neuropsychological assessment (MoCA). Methods Fastball will be migrated onto an established commercial EEG platform and embedded in clinic to validate its accuracy in dementia diagnosis and discrimination. The feasibility of Fastball use in primary care will be established, and an economic analysis of the impact of Fastball adoption in the NHS conducted. In parallel, an ambitious package of technological development, IP protection and commercialisation in partnership with Cumulus Neuroscience will ensure that there is not only the scientific evidence base for Fastball, but a commercial platform to rapidly scale up and implement the technique in the NHS. Timelines for delivery The project will provide a strong evidence base and commercial platform for scale-up, making regulatory approval, nationwide clinical implementation and patient benefit achievable within four to five years. The test may be available as an exploratory end-point in clinical trials within less than two years. Anticipated Impact and Dissemination The increase in diagnostic accuracy provided by Fastball will have significant benefits for patients, healthcare providers and the pharmaceutical industry. Earlier diagnosis would allow delivery of both symptom (e.g. donepezil) and disease modifying treatments (e.g. donanemab) at a more effective stage, and aid drug development through more accurate stratification of patients in clinical trials, and would increase the efficacy of multimodal lifestyle interventions, demonstrated to reduce the rate of cognitive decline in at-risk populations. There would be opportunities to improve cognitive function, treat depression and delay institutionalisation by implementing cognitive compensation strategies earlier. Following identification and protection of relevant IP results will be published in high impact peer-reviewed journals, and presented in international and national scientific conferences, and disseminated to the public via regional dementia research public engagement events. We will engage with the MHRA and NICE to secure Medical Device status and adoption into the NHS, and work closely with our PPI collaborators to identify, address and overcome the key concerns of patient and clinical stakeholders during Fastball adoption.