Biomedical Catalyst – Digital Healthcare Platform for Early Dementia Diagnosis

Lead Research Organisation: Imperial College London

Abstract

Most of the 700,000 people in the UK with dementia have not received a formal diagnosis, so are denied access to beneficial treatments. The current NHS approach is slow (often more than 12 months) and often of low quality. This project will develop a novel digital healthcare system that will allow dementia diagnoses to be made quickly, cost effectively, and earlier in the disease course. It makes a novel combination of computer-based tests of memory and thinking and computerized analysis of MRI brain scans, which have been used in research for several years. It will provide support in diagnosis, making available the quality of information currently only available in highly specialist centres to doctors treating all patients, with the aim of reducing time to diagnosis to 3 months. We will build and test a prototype and demonstrate its value before developing a refined prototype that can be rolled-out nationally.

Technical Summary

Most of the 700,000 people in the UK with dementia have not received a formal diagnosis, so are denied access to beneficial treatments. The current NHS approach is slow (often more than 12 months) and often of low quality. This project will develop a novel digital healthcare system that will allow dementia diagnoses to be made quickly, cost effectively, and earlier in the disease course. It makes a novel combination of computer-based tests of memory and thinking and computerized analysis of MRI brain scans, which have been used in research for several years. It will provide support in diagnosis, making available the quality of information currently only available in highly specialist centres to doctors treating all patients, with the aim of reducing time to diagnosis to 3 months. We will build and test a prototype and demonstrate its value before developing a refined prototype that can be rolled-out nationally.

Publications

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Description Quantification of Vascular Disease Burden to Stratify Dementia for Diagnosis and care management
Amount £187,534 (GBP)
Funding ID 102167 
Organisation TSB Bank plc 
Sector Private
Country United Kingdom
Start 04/2015 
End 03/2017
 
Company Name IXICO 
Description IXICO was co-founded by Professor Rueckert in 2004. IXICO's innovative technologies help those involved in researching and treating serious diseases to make rapid decisions and improve patient outcomes. Its clinical focus is predominantly dementia, but IXICO also support clinical studies for other disease areas in the field of neuro-degeneration and beyond. IXICO works with many of the leading pharmaceutical companies providing clinical trial services and technology to evaluate imaging endpoints as part of their drug development pipelines. Its medical image management and analysis products are used by the global pharmaceutical industry to select patients for clinical trials and to assess the safety and efficacy of drugs in development. 
Year Established 2004 
Impact Economic impacts IXICO had a significant impact on the pharmaceutical industry where medical imaging is rapidly becoming an important tool in clinical trials to assess the safety and efficacy of new drugs using imaging biomarkers. IXICO's imaging biomarkers provide several benefits to pharmaceutical companies: In concept trials of AD therapies the developed biomarkers allow pharmaceutical companies to power their studies with fewer subjects. The developed imaging biomarkers do provide evidence of efficacy with around 100 subjects per arm (an "arm" in a clinical trial refers to any of the treatment groups in a randomized trial. Most randomized trials have two "arms", e.g. untreated vs. treated groups) over 12 months rather than 400 or so per arm needed for cognitive testing. Based on a conservative cost estimate of $30k per subject enrolled, this provides a significant cost saving for the companies. Similarly, pharmaceutical companies use the developed imaging biomarkers to enrich their clinical trials. In the context of clinical trials, such enrichment allows the identification of a population of patients in whom a drug effect, if present, is more likely to be demonstrable. In AD trials that use the developed biomarkers, an increase in the conversion rate in a prodromal Alzheimer's trial from 40% to 60% saves 30% off the cost of a pair of pivotal trials that used progression free survival as an endpoint, and which might otherwise cost $800m - $1bn. Impacts on public policy and services The imaging biomarkers developed in the underpinning research have had a significant impact on informing the development of new guidelines for the use of Magnetic Resonance Imaging (MRI) and low hippocampal volume in regulatory clinical trials: It now seems likely that to modify the course of Alzheimer's Disease, it is necessary to start the treatment in the pre-dementia (or prodromal) phase. The identification of patients at this stage can only be done confidently with the help of biomarkers: imaging provides a non-invasive alternative to cerebrospinal fluid (CSF) biomarkers for this purpose. The critical importance of imaging biomarkers in AD trials has been recognised by the CAMD consortium by submitting to regulators an application to qualify low hippocampal volume as a biomarker. This submission - approved by EMA and currently under review by the FDA - incorporates key data obtained using the underpinning research described here: the availability of this technology, with the regulatory qualification, is having global impact on the design of future trials of AD medicines in the pre-dementia population. In particular, the EMA Committee for Medicinal Products for Human Use has issued a positive opinion on the use of MRI to measure hippocampal volume as a tool to enrich recruitment into regulated clinical trials in the pre-dementia stages of Alzheimer's disease, in which the EMA directly refers to IXICO's technology. This was the first imaging-based biomarker to be qualified by a regulatory agency. Impacts on healthcare The imaging biomarkers developed in the underpinning research have been so effective in clinical trials that IXICO has recently decided also to develop products for diagnostic use (Brain Health Centre). IXICO's product for diagnostics directly uses the methods described in reference of the underpinning research and has also been CE marked. It is currently undergoing trials involving 200 patients as part of new NHS brain health centres.
Website http://www.ixico.com